Trials / Recruiting
RecruitingNCT05580562
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 510 (estimated)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dordaviprone (ONC201) | 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. |
| DRUG | Dordaviprone (ONC201) + Placebo | 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 |
| OTHER | Placebo | Participants will receive placebo (same number of capsules as the dordaviprone dose) on dosing days |
Timeline
- Start date
- 2023-01-23
- Primary completion
- 2028-06-01
- Completion
- 2028-06-01
- First posted
- 2022-10-14
- Last updated
- 2026-04-16
Locations
162 sites across 18 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Denmark, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05580562. Inclusion in this directory is not an endorsement.