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NCT07486713 · ClinicalTrials.gov registry record · Phase 4
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
A Phase 4 study of Glioma and Cholangiocarcinoma, sponsored by Rigel Pharmaceuticals.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
- 2
- Study locations
NCT07486713: Recruiting Phase 4 study of Glioma and Cholangiocarcinoma, sponsored by Rigel Pharmaceuticals.
NCT07486713 is a Phase 4 study of Glioma and Cholangiocarcinoma that is actively recruiting participants, run by Rigel Pharmaceuticals. The registered enrollment target is 16 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07486713, a Phase 4 study of Glioma and Cholangiocarcinoma, is actively recruiting participants, sponsored by Rigel Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
To evaluate how olutasidenib affects the overall exposure of several test drugs (probe substrates) that are used to measure the activity of certain enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4) and a drug transporter (OATP1B1). This will be assessed by measuring the area under the plasma concentration-time curve after the probe drugs are taken alone and again after treatment with olutasidenib.
Conditions Studied
Interventions
- DRUG Olutasidenib
- DRUG CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates
Study Locations (2)
California
- UCI Irvine Health - Orange
New York
- New York Presbyterian Hospital-Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2026-02-23 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 4 |
What NCT07486713 shows while recruiting
NCT07486713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Glioma appearing as the primary indexed condition, and to 2 interventions - of which Olutasidenib is the first listed.
NCT07486713 reports a single indexed study location in California, New York.
Frequently Asked Questions
What is clinical trial NCT07486713 about?
NCT07486713 is a clinical study titled "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.
What is the current status of trial NCT07486713?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2026-02-23. Estimated completion is 2027-06-30.
What conditions does trial NCT07486713 study?
This clinical trial studies the following conditions: Glioma, Cholangiocarcinoma, Solid Tumor Malignancies, AML (Acute Myeloid Leukemia).
What interventions are being tested in trial NCT07486713?
The interventions under investigation include: Olutasidenib (DRUG), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates (DRUG).
Who is sponsoring clinical trial NCT07486713?
This trial is sponsored by Rigel Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07486713 being conducted?
This trial has 2 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07486713's enrollment target sits among peer trials
16 76th of 87 higher than 12 of 87 other Glioma trials
participants (enrollment target), bucketed by value
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