MedTrace Logo

Study of Olutasidenib and Temozolomide in HGG

NCT06161974 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-21

No results posted yet for this study

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.

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

DRUG

Olutasidenib + TMZ

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

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER

  • Rigel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Santosh Valvi, FRACP, MSc · Perth Children's Hospital

  • Nicholas G Gottardo, MB FRACP PhD · Perth Children's Hospital

  • Michael J Fisher, MD · Children's Hospital of Philadelphia

  • Maryam Fouladi, MD · Nationwide Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2029-06-30
Completion
2035-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161974 on ClinicalTrials.gov