Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05580562 | ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study) | PHASE3 | RECRUITING | 510 | — | — | Jan 23, 2023 | Jun 1, 2028 | Apr 16, 2026 | 162 | United States, Argentina +16 |
Overall Survival is defined as the time from randomization to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Dordaviprone Twice Weekly Group | EXPERIMENTAL | - |
| Dordaviprone Once Weekly Group | EXPERIMENTAL | - |
| Placebo Group | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Dordaviprone (ONC201) | DRUG | 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. |
| Dordaviprone (ONC201) + Placebo | DRUG | 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 |
| Placebo | OTHER | Participants will receive placebo (same number of capsules as the dordaviprone dose) on dosing days |
Inclusion Criteria: 1. Able to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable. 2. Body weight ≥ 10 kg at time of randomization. 3. Histologically diagnosed ...