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 BAY 1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML)
The goal of the pre-screening part of this clinical research study is to learn if you have a certain kind of mutation (genetic change) called IDH1. Only patients who have this mutation will be able to take part in the main part of the study. The goal of the main part of this study is to find the highest tolerable or recommended dose of BAY 1436032 that can be given to patients with advanced or refractory (has not responded to treatment) acute myeloid leukemia (AML) that has a certain kind of mutation called IDH1. The safety and tolerability of this drug will also be studied.
Disease Group: Other diseases of blood and blood-forming organs
Treatment Agent: BAY 1436032
Treatment Location: Both at MDACC & and Other Sites
Sponsor: Bayer HealthCare Pharmaceuticals Inc.
IRB Review and Approval Date: 06/02/2017
Recruitment Status: Open
Projected Accrual: approximately 60
Information and next steps
Other diseases of blood and blood-forming organs
Phase I/Phase II
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