A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients with IDH1 Mutation-Positive Malignancies Being

This is a research study that involves studying olutasidenib in participants whose tumors have a specific change in a gene called IDH1 (known as IDH1m+). This gene change can affect how the tumor grows and responds to treatment. The purpose of the study is to gather additional information about how the study drug, olutasidenib, behaves in the body and how it interacts with other medications, specifically with caffeine, bupropion, pioglitazone, losartan, lansoprazole, triazolam, and pravastatin. The study will also assess the safety and tolerability of these drugs when taken together. This study aims to better understand how olutasidenib affects the way the body processes these drugs and whether the combination is safe and well-tolerated. Olutasidenib is an anticancer medication approved by the U.S. Food and Drug Administration (FDA) in 2022 for the treatment of adult patients with relapsed (cancer that returns) or refractory (cancer that does not respond to treatment) acute myeloid leukemia (AML) who have a susceptible IDH1m+. In this study, olutasidenib is an investigational treatment, also called “study drug” or “study treatment,” because it has not received approval by the FDA to treat cancers other than AML.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years or older. 2. Must have a diagnosis of IDH1-mutant malignancy to be treated with olutasidenib, e.g., glioma. 3. Cannot be pregnant or breastfeeding.