OncoMatch/Clinical Trials/NCT07486713
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
Is NCT07486713 recruiting? Yes, currently enrolling (Jun 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).
Treatment: Olutasidenib · CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
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 →Frequently asked questions
Is NCT07486713 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior olutasidenib, anticancer treatment, investigational agent disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify