Trial Condition(s):
Leukemia, Myeloid, Acute
BAY1436032 in patients with mutant IDH1(mIDH1) advanced acute myeloid leukemia (AML)
Bayer Identifier:
19036
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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)
Inclusion Criteria
- Patients with advanced AML that harbors IDH1 mutation - Patients are relapsed from or refractory to at least 1 previous line of therapy - Good kidney and liver function - Male or female patients - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 - Women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal
Exclusion Criteria
- Previously treated with any prior mIDH1 targeted therapy - Extramedullary disease only - History of clinically significant or active cardiac disease - Active clinically significant infection - Unresolved chronic toxicity of previous AML treatment - Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors - Pregnancy or breast-feeding
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Universitätsklinikum Heidelberg Heidelberg, Germany, 69120 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ohio State University Columbus, United States, 43210 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Florida-Gainesville Gainesville, United States, 32608 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Roswell Park Cancer Institute Buffalo, United States, 14263-0001 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Montefiore Medical Center Bronx, United States, 10467-2490 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Wake Forest Baptist Health Winston-Salem, United States, 27157 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Pennsylvania Philadelphia, United States, 19104 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Northwestern Memorial Hospital Chicago, United States, 60611-2908 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Mount Sinai Medical Center New York, United States, 10029 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medizinische Hochschule Hannover (MHH) Hannover, Germany, 30625 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20246 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum Charite zu Berlin Berlin, Germany, 12200 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Thomas Jefferson University Philadelphia, United States, 19107 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Chicago Chicago, United States, 60637 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinikum rechts der Isar München, Germany, 81675 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Southern California Keck School of Medicine Los Angeles, United States, 90033-9172 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Northside Hospital - Atlanta Atlanta, United States, 30342 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
An open-label, non-randomized, multicenter Phase I study 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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
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 BAY1436032Timeframe: Within first 4 weeks of first dose
- Number of participants with Adverse Events as a Measure ofAs a measure of safety and tolerabilityTimeframe: Up to 12 weeks
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 diseaseTimeframe: Up to 12 weeks
- Duration of responseEfficacy dataTimeframe: Up to 12 weeks
- Event-free survival (EFS)EFS defined as time from start of treatment to treatment failure, relapse, or death due to any cause.Timeframe: Up to 12 weeks
- 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.Timeframe: Up to 12 weeks
- 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.Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hour post-dose (each cycle is 28 days)
- 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.Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, and 8 hour post-dose (each cycle is 28 days)
- AUC(0-12) (AUC from time 0 to 12 h after a single dose)if feasibleTimeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hour post-dose (each cycle is 28 days)
- 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.Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hour post-dose on Day 15; (each cycle is 28 days)
- 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.Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, and 8 hour post-dose on Day 15; (each cycle is 28 days)
- AUC(0-12)md (AUC from time 0 to 12 h after multiple doses)if feasibleTimeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, and 8 hour post-dose on Day 15; (each cycle is 28 days)
Additional Information
Not Available
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