check_circleStudy Completed
Leukemia, Myeloid, Acute
Bayer Identifier:
19036
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
BAY1436032 in patients with mutant IDH1(mIDH1) advanced acute myeloid leukemia (AML)
Trial purpose
To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML)
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
27Trial Dates
June 2017 - March 2019Phase
Phase 1Could I Receive a placebo
NoProducts
BAY1436032Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätsklinikum Heidelberg | Heidelberg, 69120, Germany |
Completed | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Completed | Ohio State University | Columbus, 43210, United States |
Withdrawn | University of Florida-Gainesville | Gainesville, 32608, United States |
Completed | Universitätsklinikum Leipzig AöR | Leipzig, Germany |
Completed | Roswell Park Comprehensive Cancer Center | Buffalo, 14263-0001, United States |
Completed | Montefiore Medical Center | Bronx, 10467-2490, United States |
Completed | Wake Forest Baptist Health | Winston-Salem, 27157, United States |
Completed | University of Pennsylvania | Philadelphia, 19104, United States |
Withdrawn | Northwestern Memorial Hospital | Chicago, 60611-2908, United States |
Completed | Mount Sinai Medical Center | New York, 10029, United States |
Completed | Medizinische Hochschule Hannover (MHH) | Hannover, 30625, Germany |
Completed | Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg, 20246, Germany |
Completed | Universitätsklinikum Charite zu Berlin | Berlin, 12200, Germany |
Completed | Thomas Jefferson University | Philadelphia, 19107, United States |
Withdrawn | University of Chicago | Chicago, 60637, United States |
Withdrawn | Klinikum rechts der Isar | München, 81675, Germany |
Withdrawn | University of Southern California Keck School of Medicine | Los Angeles, 90033-9172, United States |
Withdrawn | Northside Hospital - Atlanta | Atlanta, 30342, United States |
Withdrawn | Universitätsklinikum Essen | Essen, 45122, Germany |
Primary Outcome
- Maximum tolerated dose (MTD) or RP2D of BAY1436032If the MTD is not reached during dose escalation, the primary variable will be the recommended phase 2 dose (RP2D) of BAY1436032date_rangeTime Frame:Within first 4 weeks of first doseenhanced_encryptionYesSafety Issue:
- Number of participants with Adverse Events as a Measure ofAs a measure of safety and tolerabilitydate_rangeTime Frame:Up to 12 weeksenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Objective efficacy responseResponse assessment for AML in this study will be based on the modified Cheson criteria. The following categories are used to capture the investigator’s AML response evaluation: - Complete remission (CR) - Morphologic CR with CRh (morphologic CR with incomplete hematological recovery) and the response category CRp (morphologic CR with incomplete platelet recovery) - Partial remission (PR) - Response categories for morphologic leukemia-free state (MLFS), stable disease and progressive disease - Progressive diseasedate_rangeTime Frame:Up to 12 weeksenhanced_encryptionNoSafety Issue:
- Duration of responseEfficacy datadate_rangeTime Frame:Up to 12 weeksenhanced_encryptionNoSafety Issue:
- Event-free survival (EFS)EFS defined as time from start of treatment to treatment failure, relapse, or death due to any cause.date_rangeTime Frame:Up to 12 weeksenhanced_encryptionNoSafety Issue:
- Change of 2 hydroxyglutarate (2-HG) level obtained at baseline and post-baselineAssess pharmacodynamic (PD) effects and evidence of clinical efficacy associated with BAY 1436032 administration in patients. Change from baseline and percent change from baseline will be calculated.date_rangeTime Frame:Up to 12 weeksenhanced_encryptionNoSafety Issue:
- Cmax (maximum observed drug concentration in plasma after a single dose)As a secondary objective of this study evaluate the pharmacokinetics (PK) of BAY 1436032 in patients. PK parameters normalized for dose and / or dose and body weight will be calculated.date_rangeTime Frame:Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hour post-dose (each cycle is 28 days)enhanced_encryptionNoSafety Issue:
- AUC(0-8) (AUC from time 0 to 8 h after a single dose)As a secondary objective of this study evaluate the pharmacokinetics (PK) of BAY 1436032 in patients. PK parameters normalized for dose and / or dose and body weight will be calculated.date_rangeTime Frame:Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, and 8 hour post-dose (each cycle is 28 days)enhanced_encryptionNoSafety Issue:
- AUC(0-12) (AUC from time 0 to 12 h after a single dose)if feasibledate_rangeTime Frame:Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hour post-dose (each cycle is 28 days)enhanced_encryptionNoSafety Issue:
- Cmax,md (Cmax after multiple doses)As a secondary objective of this study evaluate the pharmacokinetics (PK) of BAY 1436032 in patients. PK parameters normalized for dose and / or dose and body weight will be calculated.date_rangeTime Frame:Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hour post-dose on Day 15; (each cycle is 28 days)enhanced_encryptionNoSafety Issue:
- AUC(0-8)md (AUC from time 0 to 8 h after multiple doses)As a secondary objective of this study evaluate the pharmacokinetics (PK) of BAY 1436032 in patients. PK parameters normalized for dose and / or dose and body weight will be calculated.date_rangeTime Frame:Pre-dose, 0.5, 1, 2, 3, 4, 6, and 8 hour post-dose on Day 15; (each cycle is 28 days)enhanced_encryptionNoSafety Issue:
- AUC(0-12)md (AUC from time 0 to 12 h after multiple doses)if feasibledate_rangeTime Frame:Pre-dose, 0.5, 1, 2, 3, 4, 6, and 8 hour post-dose on Day 15; (each cycle is 28 days)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1