At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed H3 K27M-mutant diffuse glioma (new diagnosis)
- ✓Body weight ≥10 kg at randomization
- ✓K27M mutation detected by IHC or NGS in CLIA-certified laboratory
- ✓Contrast-enhanced brain MRI prior to radiotherapy (post-resection if surgery performed)
- ✕Primary spinal tumor
- ✕Diffuse intrinsic pontine glioma (DIPG)
- ✕Leptomeningeal spread or cerebrospinal fluid dissemination
- ✕Concurrent malignancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
In Brief
A Phase 3 clinical trial evaluating Dordaviprone (ONC201), Dordaviprone (ONC201) + Placebo, and 1 other intervention for H3 K27M and Glioma. Currently recruiting, targeting 510 participants across 162 sites in 18 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants ≥ 52.5 kg will receive 625 mg of dordaviprone (5 × 125-mg capsules) dosing days; participants \< 52.5 kg will receive a dose (and corresponding number of capsules) scaled by body weight and rounded to 125-mg increments.
Participants ≥ 52.5 kg will receive 625 mg of dordaviprone (5 × 125-mg capsules) or matching placebo on dosing days; participants \< 52.5 kg will receive a dose (and corresponding number of capsules) scaled by body weight and rounded to 125-mg increments
Participants will receive placebo (same number of capsules as the dordaviprone dose) on dosing days