RecruitingPhase 2NCT06161974

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

Sponsor

Rigel Pharmaceuticals

Enrollment

60 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Brain Tumor IDH1 Mutation Astrocytoma, Grade IV Oligodendroglioma Astrocytoma, Grade III High Grade Glioma Diffuse Intrinsic Pontine Glioma WHO Grade III Glioma WHO Grade IV Glioma Astrocytoma Diffuse Midline Glioma, H3 K27M-Mutant Thalamus Tumor Spinal Tumor IDH1 R132 IDH1 R132C IDH1 R132H IDH1 R132S IDH1 R132G IDH1 R132L

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.

Eligibility

Min Age: 12 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — olutasidenib (an IDH1 inhibitor) and temozolomide (a standard chemotherapy) — in people with high-grade glioma (aggressive brain tumors) that have the IDH1 mutation. It also includes people with IDH-wildtype gliomas and other rare brain tumors. **You may be eligible if...** - You are 18 or older with a high-grade brain tumor (glioma, glioblastoma, or related type) - Your tumor has the IDH1 R132H mutation (confirmed by testing) — or you have IDH-wildtype HGG or rare CNS tumors in specific parts of the study - Your tumor has recurred or progressed after standard treatment - You are able to function with some independence (KPS score of 60 or higher) **You may NOT be eligible if...** - You have uncontrolled seizures or serious neurological deterioration - You have had prior treatment with IDH inhibitors - You have serious liver, kidney, or heart conditions - You are pregnant or breastfeeding - You are on strong medications that interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlutasidenib + TMZ

Olutasidenib 150 mg PO BID + Temozolomide 200 mg/m2 PO QD

Locations(18)

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Susan Chi

Boston, Massachusetts, United States

Duke University Health System

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Sydney Children's Hospital

Randwick, New South Wales, Australia

Queensland Children's Hospital

South Brisbane, Queensland, Australia

Perth Children's Hospital

Perth, Western Australia, Australia

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)

Heidelberg, Baden-Wurttemberg, Germany

Princess Máxima Center

Utrecht, Netherlands

Great Ormond Street Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06161974

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