Clinical Trial

ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)

Study acronym: ACTION
Recruiting Phase 3
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Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.
Protocol Amendment History 65 amendments
This ClinicalTrials.gov record has been amended 65 times since 2022-10-12; most recent amendment 2026-04-13.
Status change: Not Yet Recruiting → Recruiting 2022-11-15
Trial Details
NCT Number NCT05580562
Lead Sponsor Jazz Pharmaceuticals
Collaborators: Chimerix, Inc.
Conditions H3 K27M, Glioma
Enrollment 510 participants
Start Date 2023-01-23
Primary Completion 2028-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-16