NCT06161974Phase 2Recruiting

Study of Olutasidenib and Temozolomide in HGG

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2029-06Estimated

Enrollment · participants60Estimated

Source updated2026-09-01Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

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

Treatments or interventions studied

Olutasidenib + TMZDrug

Primary outcomes · main study measures

Read the study measures

measure: Establish the RP2D of Olutasidenib and Temozolomide (Feasibility cohort); description: To identify the dose of olutasidenib that is feasible when given post-RT in combination with temozolomide as maintenance therapy in pediatric and young adult patients newly diagnosed with IDH1-mutant high-grade glioma; timeFrame: Completion of cycle 1 (28 days) for 6-24 patients; measure: Assess Progression-Free Survival (PFS) in Grade 3 IDH1-mutant Astrocytoma (Stratum A); description: To assess the post-RT efficacy of olutasidenib in newly diagnosed patients with WHO Grade 3 IDH1-mutant Astrocytoma treated with maintenance olutasidenib and temozolomide for 13 cycles followed by 13 cycles of single agent olutasidenib compared to molecularly-stratified and matched historical controls; 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; measure: Maximum plasma concentration [Cmax] of Olutasidenib; description: To characterize the plasma pharmacokinetic (PK) properties of olutasidenib in pediatric patients (e.g., 12 to \< 18 years of age), administered in combination with temozolomide (first year) and as single agent (second year) as maintenance chemotherapy by measuring the Maximum Concentration \[Cmax\] and Area Under the Curve (AUC) of olutasidenib in plasma (All strata).; 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

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history