NCT07486713
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
Recruiting · Phase 4 · Rigel Pharmaceuticals · registry updated 2026-08-11
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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).
Exclusion
- Female patients who are pregnant or breastfeeding.
- Patients who are active smokers. Those who have ceased smoking \> 1 month before the Screening Visit will be allowed.
- Ingestion of alcohol within 72 hours prior to first study drug administration and during the study period.
- Any patient's who plans to become pregnant or father a child (including ova or sperm donation) while enrolled in this study or within 3 months after last dose of study drug.
- Known allergy or history of hypersensitivity to study drugs or their excipients.
- Human immunodeficiency virus (HIV) positivity.