NCT06161974

Study of Olutasidenib and Temozolomide in HGG

Phase 2 Study of Olutasidenib with Temozolomide As Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed with High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, international, phase II study of post-radiotherapy (RT) administration of olutasidenib to treat pediatric and young adult patients newly diagnosed with an IDH1-mutant HGG. The trial will include a feasibility cohort to identify the dose of olutasidenib that is feasible when given in combination with temozolomide as maintenance therapy after completion of focal radiotherapy in this patient population. Efficacy will be defined by progression-free survival (PFS) distribution of these patients after completion of radiotherapy treated with maintenance olutasidenib and TMZ for 13 cycles followed by 13 cycles of single agent olutasidenib compared to molecularly-stratified and matched historical controls. Objective radiographic response rates, agent-specific toxicities as well as the pharmacokinetic and pharmacodynamic properties of olutasidenib will also be assessed.

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

Interventions

Type	Name	Description
DRUG	Olutasidenib + TMZ	Olutasidenib 150 mg PO BID + Temozolomide 200 mg/m2 PO QD

Timeline

• Start date: 2025-03-01
• Primary completion: 2029-06-01
• Completion: 2035-06-01
• First posted: 2023-12-08
• Last updated: 2025-02-21

Locations

18 sites across 6 countries: United States, Australia, Canada, Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study