Olutasidenib for Cancer

Recruiting at 1 trial location

Overseen By Jill DeFratis

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rigel Pharmaceuticals

Must not be taking: CYP inhibitors, CYP inducers

Disqualifiers: Pregnancy, HIV, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old or older.

I am a woman who can become pregnant and have a recent negative pregnancy test.

* WOCBP, must agree to use two methods of birth control (e.g. hormonal and a barrier method such as a condom), or must be considered highly unlikely to conceive during the dosing period and for 3 months after last study treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olutasidenib twice daily from Day 5 to Day 22, along with a single dose of probe substrates on Day 1 and Day 18

3 weeks

Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events

4 weeks

Follow-up visits for safety monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Olutasidenib

How Is the Trial Designed?

Group I: Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates Experimental Treatment 2 Interventions

Participants will receive olutasidenib twice daily from Day 5 to Day 22. Participant will also receive a single dose of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 probe substrates on Day 1 and Day 18.

Who Is Running the Clinical Trial?

Rigel Pharmaceuticals

Lead Sponsor

Trials

37

Recruited

4,000+