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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06780930 | Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation | PHASE3 | ACTIVE NOT_RECRUITING | 57 | — | — | Oct 18, 2024 | Oct 31, 2030 | Jan 9, 2026 | 8 | China, Taiwan |
The time from date of randomization to date of first documented radiographic progressive disease (PD), as assessed by the Blinded Independent Review Committee (BIRC), or date of death due to any cause, whichever occurs earlier.
| Arm | Type | Description |
|---|---|---|
| Randomized Double-Blind Phase: Vorasidenib | EXPERIMENTAL | - |
| Randomized Double-Blind Phase: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Vorasidenib | DRUG | For oral administration once daily |
| Placebo | DRUG | For oral administration once daily |
Inclusion Criteria: * Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg. * Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants \<16 years of age) of ≥80%. * Have Gra...