RecruitingPhase 2

Study of Olutasidenib and Temozolomide in HGG

United States, Australia, Canada60 participantsStarted 2025-02-01

Plain-language summary

The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.

Who can participate

Age range

12 Years – 39 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:
.1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR 1.2) Diagnosis:
.3) Disease status: There are no disease status requirements for enrollment
. Inclusion criteria for assignment to TarGeT-D, for all strata:
.1 Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here:
.2 Weight: Patients must weigh ≥35 Kg (77 lbs) at the time of enrollment on TarGeT-D.
.3 Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1My tumor has an IDH1 mutation — does my specific IDH1 variant, like R132H or one of the other types listed in this trial, actually match what they're testing with olutasidenib?
2This is a Phase 2 trial that's still figuring out the right dose of olutasidenib combined with temozolomide in a 'feasibility cohort' — what does that mean for what's already known about safety, and how does that compare to just using temozolomide on its own as a standard option?
3The trial is measuring progression-free survival specifically in Grade 3 IDH1-mutant astrocytoma — if my diagnosis is a different grade or a different tumor type like oligodendroglioma, would I be in a separate group and would the goals of the study be different for me?
4Part of what this trial is tracking is how much olutasidenib gets into my bloodstream — does that mean there will be extra blood draws or monitoring visits beyond what my normal care would involve, and how would that fit into my schedule?
5Are there currently approved treatments for my specific IDH1-mutant tumor that I should consider first before a Phase 2 study, or does my doctor think this trial could be a better path given where my disease stands right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Establish the RP2D of Olutasidenib and Temozolomide (Feasibility cohort)

Timeframe: Completion of cycle 1 (28 days) for 6-24 patients

Assess Progression-Free Survival (PFS) in Grade 3 IDH1-mutant Astrocytoma (Stratum A)

Timeframe: From date of diagnosis until date of Progressive Disease or death due to any cause or date of last follow-up, assessed up 24 months

Maximum plasma concentration [Cmax] of Olutasidenib

Timeframe: From Day 1 of treatment until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 24 months

Trial details

NCT IDNCT06161974

SponsorRigel Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06

Contact for this trial

Jill DeFratis, MPH

650-624-1100 jdefratis@rigel.com

View on ClinicalTrials.gov More High Grade Glioma trials

Plain-language summary

Who can participate

Age range

12 Years – 39 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:
.1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR 1.2) Diagnosis:
.3) Disease status: There are no disease status requirements for enrollment
. Inclusion criteria for assignment to TarGeT-D, for all strata:
.1 Presence of at Least One Relevant Actionable Somatic Mutation in IDH1 Gene, Detailed Here:
.2 Weight: Patients must weigh ≥35 Kg (77 lbs) at the time of enrollment on TarGeT-D.
.3 Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.

What they're measuring

Establish the RP2D of Olutasidenib and Temozolomide (Feasibility cohort)

Timeframe: Completion of cycle 1 (28 days) for 6-24 patients

Assess Progression-Free Survival (PFS) in Grade 3 IDH1-mutant Astrocytoma (Stratum A)

Timeframe: From date of diagnosis until date of Progressive Disease or death due to any cause or date of last follow-up, assessed up 24 months

Maximum plasma concentration [Cmax] of Olutasidenib

Timeframe: From Day 1 of treatment until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 24 months

Study of Olutasidenib and Temozolomide in HGG

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Study of Olutasidenib and Temozolomide in HGG

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria