drugset / Trial / NCT06161974

Study of Olutasidenib and Temozolomide in HGG

NCT06161974

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-02-01
Primary completion
2029-06
Completion
2035-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Olutasidenib Small molecule 150 mg Oral
Background Temozolomide Small molecule 200 mg/m2 Oral