Actively Recruiting
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
Led by Rigel Pharmaceuticals · Updated on 2026-03-20
16
Participants Needed
2
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of signing consent
- Eastern Cooperative Oncology Group performance status of 2 or less
- Recovered from prior non-blood related treatment side effects to Grade 1 or baseline (except infertility, hair loss, or Grade 1 neuropathy)
- Diagnosis of IDH1 mutation-positive malignancy to be treated with olutasidenib (e.g. AML, gastrointestinal cancers, glioma)
- No olutasidenib treatment within 2 weeks prior to first study drug dose
- Adequate organ function: AST and ALT 64; 2.5 times upper limit of normal (ULN)
- Bilirubin 64; 1.5 times ULN (or 64; 3 times ULN for Gilbert Syndrome, or 64; 3 times ULN for AML involvement)
- Creatinine clearance 65; 30 mL/min (Cockcroft-Gault equation)
- Female participants of childbearing potential must have negative pregnancy tests within 24 hours before first drug dose
- Women of childbearing potential must agree to use two forms of birth control or be unlikely to conceive during dosing and for 3 months after last treatment
- Male participants with partners of childbearing potential must agree to use effective contraception during dosing and for 3 months after last treatment
- Male participants must not donate sperm during dosing and for 3 months after last treatment
You will not qualify if you...
- Pregnant or breastfeeding females
- Current active smokers (those who stopped smoking more than 1 month before screening are allowed)
- Alcohol use within 72 hours before first drug dose or during the study
- Planning to become pregnant or father a child during the study or within 3 months after last drug dose
- Known allergy or hypersensitivity to study drugs or their components
- HIV positive
- Positive hepatitis B surface antigen or hepatitis C antibody or RNA at screening
- Serious infections requiring IV or systemic antibiotics within 7 days before study treatment or active infections impacting safety
- Use of moderate or strong CYP1A2, 2B6, 2C8, 2C9, 2C19, or 3A4 inhibitors or inducers within 14 days or 5 half-lives before first drug dose
- History or active significant cardiovascular, respiratory, gastrointestinal, renal, liver, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorders affecting study conduct or drug metabolism
- Less than minimum required time since prior cancer treatment or investigational agents (4 weeks or 6 weeks for long-acting agents)
- History of second malignancy unless disease-free for 12 months or surgically cured
- Symptomatic central nervous system metastases or other tumors needing urgent intervention
- Prolonged QTc interval (>480 msec) on repeated testing
- New York Heart Association Class III or IV heart failure
AI-Screening
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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
Not Yet Recruiting
Research Team
K
Kay Patel
CONTACT
J
Jill DeFratis
CONTACT
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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