Study of Olutasidenib and Temozolomide in HGG
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
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
No warning signs right now. That's why the score is 0.
Score over time
- Stage
- Phase 2
- Patients
- 60 (planned)
- Started
- Feb 1, 2025
- Main results expected
- Jun 2029
- Fully finished
- Jun 2035
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Establish the RP2D of Olutasidenib and Temozolomide (Feasibility cohort)
Measured over: Completion of cycle 1 (28 days) for 6-24 patients
Assess Progression-Free Survival (PFS) in Grade 3 IDH1-mutant Astrocytoma (Stratum A)
Measured over: 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 over: 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
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT06161974 · record last updated 2026-09-01 · checked 2026-11-09 15:47 UTC