Study of Olutasidenib and Temozolomide in HGG

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.

Trial Details

NCT ID
NCT06161974
Phase
PHASE2
Sponsor
Rigel Pharmaceuticals
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Olutasidenib + TMZ
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Miami, Florida, United States|25.77427,-80.19366
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:
  • 1) Age: patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR 1.2) Diagnosis:
  • Patients with a newly-diagnosed IDH1-mutant HGG including DIPG are eligible. All patients must have tumor tissue from diagnostic biopsy or resectio…
  • For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, and histopatholog…

For full eligibility, visit ClinicalTrials.gov.

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