NCT07486713 Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
| NCT ID | NCT07486713 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rigel Pharmaceuticals |
| Condition | AML (Acute Myeloid Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2027-04-30 |
Trial Parameters
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Brief Summary
A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.
Eligibility Criteria
Inclusion Criteria: * Adult male or female ≥ 18 years of age at the time of signing the informed consent form * Must have an Eastern Cooperative Oncology Group performance status ≤ 2. * Must have recovered from the non-hematologic toxic effects of prior treatment to Grade ≤ 1, or baseline value (excluding infertility, alopecia, or Grade 1 neuropathy) * Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia \[AML\], gastrointestinal \[GI\] cancers, glioma). Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug. * Patient must have an adequate organ function, defined by the following: * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≤ 2.5 × upper limit of normal (ULN). * Bilirubin ≤ 1.5× ULN (≤ 3 × ULN in patients with Gilbert Syndrome) or ≤ 3 × ULN for patients with AML involvement. * Creatinine clearance ≥ 30 mL/min using Cockcroft-Gault equation. * Female patie
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