Actively Recruiting
A Multi-Center, Open-Label Drug Interaction Study to Evaluate Olutasidenib's Effect on CYP and OATP1B1 Probe Substrates in Patients With IDH1 Mutation-Positive Malignancies
Led by Rigel Pharmaceuticals · Updated on 2026-06-05
16
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the drug olutasidenib affects the way the body processes certain probe drugs related to liver enzymes and transporters in adults with cancers that have a specific IDH1 mutation. This open-label, phase 4 study focuses on participants with IDH1 mutation-positive malignancies, including acute myeloid leukemia, glioma, cholangiocarcinoma, and other solid tumors. The goal is to understand drug interactions to help guide safe and effective use of olutasidenib in these patients. Participants will receive olutasidenib twice daily from Day 5 through Day 22, with an option to continue treatment until Day 64. They will also take a single dose of a cocktail of probe drugs that test several liver enzymes and transporters on Day 1 before olutasidenib starts, and again on Day 18 after olutasidenib has reached steady state. This design allows researchers to compare how olutasidenib influences the processing of these probe drugs over time. During the study, participants will have blood samples taken up to 96 hours after each probe drug administration to measure drug levels and metabolism. Researchers will evaluate how olutasidenib changes the exposure and clearance of the probe drugs. Safety will be monitored through recording any side effects from the treatments for about 30 days after the last dose. The total study participation duration may extend up to 64 days or longer if treatment continues, with detailed assessments throughout.
CONDITIONS
Brief Title
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female 18 years of age or older at the time of consent
- Eastern Cooperative Oncology Group performance status of 2 or less
- Recovery from prior treatment's non-hematologic side effects to Grade 1 or baseline (except infertility, alopecia, or Grade 1 neuropathy)
- Diagnosis of IDH1 mutation-positive malignancy treated with olutasidenib (e.g., AML, gastrointestinal cancers, glioma)
- No olutasidenib use within 2 weeks prior to first study dose
- Adequate organ function: AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin ≤ 1.5 times upper limit of normal (≤ 3 times for Gilbert Syndrome; ≤ 3 times for AML involvement)
- Creatinine clearance ≥ 30 mL/min calculated by Cockcroft-Gault equation
- Women of childbearing potential must have negative pregnancy tests within 24 hours prior to first dose
- Women of childbearing potential must use two methods of birth control or be highly unlikely to conceive during dosing and 3 months after
- Male patients with female partners of childbearing potential must agree to use effective contraception during dosing and 3 months after
- Male patients must refrain from sperm donation during dosing and for 3 months after last study treatment
You will not qualify if you...
- Pregnant or breastfeeding women
- Active smokers (must have quit more than 1 month before screening)
- Alcohol use within 72 hours prior to first study drug and during study
- Plans to become pregnant or father a child during study or within 3 months after last dose
- Known allergy or hypersensitivity to study drugs or excipients
- HIV positive
- Positive hepatitis B surface antigen or hepatitis C virus at screening
- Serious infection requiring antibiotics within 7 days before study or active infection affecting safety
- Use of moderate or strong CYP inhibitors or inducers within 14 days or 5 half-lives before first dose
- Clinically significant disorders affecting study conduct or drug metabolism
- Recent anticancer treatment or investigational agents within specified timeframes
- Prior second malignancy unless disease-free for 12 months or surgically cured
- Symptomatic central nervous system metastases or other urgent tumor-related conditions
- Marked QT/QTc prolongation > 480 msec
- New York Heart Association Class III or IV heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 64 days
Participants receive a single dose of CYP and OATP1B1 probe substrates on Day 1 and Day 18. They take olutasidenib twice daily from Day 5 to Day 22, with an option to continue treatment up to Day 64.
Multiple visits including dosing on Days 1, 5 to 22, 18, and optional follow-up visits up to Day 64
Duration - Approximately 30 days after last treatment dose
Participants are monitored for treatment-emergent adverse events from the start of treatment through approximately 30 days after the last dose of study treatment.
1 to 2 visits depending on individual participant needs
Trial Site Locations
Total: 2 locations
1
UCI Irvine Health
Orange, California, United States, 92868
Actively Recruiting
2
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
K
Kay Patel
J
Jill DeFratis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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