BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)
Study Phase: Phase 1
Recruitment Status: Recruiting
Start Date: June 14, 2017
End Date: October 11, 2019
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
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Conditions:
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute