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OncoMatch/Clinical Trials/NCT07486713

Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies

Is NCT07486713 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Olutasidenib and CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates for aml (acute myeloid leukemia).

Phase 4RecruitingRigel PharmaceuticalsNCT07486713Data as of May 2026

Treatment: Olutasidenib · CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe SubstratesA 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Glioblastoma

Cholangiocarcinoma

Tumor Agnostic

Biomarker criteria

Required: IDH1 mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: olutasidenib (olutasidenib)

Exception: must not have received olutasidenib within the 2 weeks prior to the first dose of study drug

Patient should not have received olutasidenib within the 2 weeks prior to the first dose of study drug.

Cannot have received: anticancer treatment

Exception: minimum time must have elapsed from prior anticancer treatment to first dose of study treatment: cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, or major surgery within 4 weeks prior to the first scheduled study treatment; for longer acting agents such as nitrosourea, mitomycin or antibody therapies, a minimum of 6 weeks.

Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, or major surgery within 4 weeks prior to the first scheduled study treatment; for longer acting agents such as nitrosourea, mitomycin or antibody therapies, a minimum of 6 weeks.

Cannot have received: investigational agent

Exception: within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent)

Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent).

Lab requirements

Kidney function

creatinine clearance ≥ 30 ml/min using cockcroft-gault equation

Liver function

ast and alt values ≤ 2.5 × uln; bilirubin ≤ 1.5× uln (≤ 3 × uln in patients with gilbert syndrome) or ≤ 3 × uln for patients with aml involvement

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UCI Irvine Health · Orange, California
  • New York Presbyterian Hospital-Columbia University Medical Center · New York, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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