Actively Recruiting
Phase 3 Study of ONC201 Dordaviprone for Newly Diagnosed H3 K27M-mutant Diffuse Glioma After Radiotherapy
Led by Jazz Pharmaceuticals · Updated on 2026-04-16
510
Participants Needed
162
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying patients with newly diagnosed H3 K27M-mutant diffuse glioma to see if the drug dordaviprone ONC201 after standard radiotherapy can help extend overall survival and delay disease progression. This international Phase 3 trial is randomized, double-blind, and placebo-controlled to carefully evaluate treatment effects in this specific patient group. Participants must have a confirmed diagnosis of this glioma subtype and have completed frontline radiotherapy. Participants are randomly assigned to one of three groups dordaviprone taken twice weekly, dordaviprone taken once weekly, or a matching placebo. Dosing is adjusted based on body weight, with a standard dose of 625 mg for patients weighing 52.5 kg or more. The study treatment starts after completion of radiotherapy and continues under close monitoring. Throughout the study, participants undergo regular assessments including brain MRIs, laboratory tests, and evaluations of neurological function and quality of life. Researchers will monitor overall survival over approximately 44 months, as well as progression-free survival, corticosteroid use, performance status, and symptom changes. Safety and lab parameters will be tracked closely to understand treatment effects and participant well-being during the trial period.
CONDITIONS
Brief Title
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Research Team
C
Clinical Trial Disclosure & Transparency
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