Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Phase 3
Active, not recruiting
NCT04164901
| Condition | Grade 2 Glioma, Residual Glioma, Recurrent Glioma |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | Institut de Recherches Internationales Servier |
|---|
| Status | Active, not recruiting |
|---|
| Enrollment | 331 participants |
|---|
| Interventions | Vorasidenib, Matching Placebo |
|---|
| Start date | Jan 5, 2020 |
|---|
| Completion date | Sep 6, 2022 |
|---|
| Results posted | Nov 24, 2023 |
|---|
Summary
Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.
Progression-Free Survival (PFS)
Up to approximately 30 months · months
| Vorasidenib | 27.7 months |
|---|
| Matching Placebo | 11.1 months |
|---|
| p-value | <0.0000001 |
|---|
| Cox Proportional Hazard | 0.39 (95% CI 0.27–0.56) |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.