Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies

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.

Trial Details

NCT ID
NCT07486713
Phase
PHASE4
Sponsor
Rigel Pharmaceuticals
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Olutasidenib
  • CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311
  • New York, New York, United States|40.71427,-74.00597

Key Eligibility 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 …
  • Must have a diagnosis of IDH1m+ malignancy to be treated with olutasidenib (e.g. acute myeloid leukemia \[AML\], gastrointestinal \[GI\] cancers, g…

For full eligibility, visit ClinicalTrials.gov.

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