clinical trial · NCT05580562
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
H3 K27MGliomaDordaviprone (ONC201)Dordaviprone (ONC201) + PlaceboPlacebo
brief 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.
started
Jan 23, 2023
primary completion
Jun 1, 2028
completion
Jun 1, 2028
last updated
Apr 16, 2026
official title
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol