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

• Status: Completed
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

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