Study of Olutasidenib and Temozolomide in HGG
← catalyst calendarNCT06161974 · readout ≤ 1,045 d
Sponsored by Rigel Pharmaceuticals (industry) · RIGL — their whole pipeline →. With Nationwide Children's Hospital.
Phase
Phase 2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
60estimated
Sites
20
Countries
Australia, Canada, Germany +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-02-01 | actual | When the study began enrolling |
| Primary completion | Jun 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2035 | estimated | The whole study's end, after follow-up |
| First posted | 2023-12-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- High Grade Glioma
- Astrocytoma
- Astrocytoma, Grade III
- Astrocytoma, Grade IV
- Diffuse Intrinsic Pontine Glioma
- WHO Grade III Glioma
- WHO Grade IV Glioma
- Metastatic Brain Tumor
- Diffuse Midline Glioma, H3 K27M-Mutant
- Thalamus Tumor
- Spinal Tumor
- IDH1 Mutation
- IDH1 R132
- IDH1 R132C
- IDH1 R132H
- IDH1 R132S
- IDH1 R132G
- IDH1 R132L
- Oligodendroglioma
Intervention
- Drug: Olutasidenib + TMZ
Primary outcomes
what the primary-completion date above is the date OFEstablish the RP2D of Olutasidenib and Temozolomide (Feasibility cohort)
measured Completion of cycle 1 (28 days) for 6-24 patients
Assess Progression-Free Survival (PFS) in Grade 3 IDH1-mutant Astrocytoma (Stratum A)
measured 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
measured 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
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