BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)
Leukemia, Myeloid, Acute
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Phase 1, mIDH1, IDH1 mutation, mIDH1 inhibitor
Eligibility Criteria
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
Sites / Locations
- Montefiore Medical Center
- Roswell Park Comprehensive Cancer Center
- Mount Sinai Medical Center
- Wake Forest Baptist Health
- Ohio State University
- University of Pennsylvania
- Thomas Jefferson University
- University of Texas MD Anderson Cancer Center
- Universitätsklinikum Heidelberg
- Medizinische Hochschule Hannover (MHH)
- Universitätsklinikum Leipzig AöR
- Universitätsklinikum Charite zu Berlin
- Universitätsklinikum Hamburg Eppendorf (UKE)
Arms of the Study
Arm 1
Experimental
BAY1436032
Dose escalation: Various doses of study drug will be tested on a small number of patients/dose with the goal of identifying the most appropriate dose(s) for further evaluation in dose expansion. The MTD of the study drug may or may not be identified. It is anticipated that 3-4 patients will be treated at each dose of study drug to be tested and that 15-20 total patients will be treated in this part of the trial. Dose expansion: Up to 2 different doses of study drug will be tested on up to 30 patients/dose with the goal of identifying the most appropriate RP2D for further clinical development. The doses to be evaluated in this part of the trial will be selected based on information obtained during dose escalation.