BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)

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)

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