NCT04164901

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Grade 2 Glioma
• Residual Glioma
• Recurrent Glioma

Interventions

Type	Name	Description
DRUG	Vorasidenib	Vorasidenib oral film-coated tablets
DRUG	Matching Placebo	Matching Placebo oral tablets

Timeline

• Start date: 2020-01-05
• Primary completion: 2022-09-06
• Completion: 2028-05-01
• First posted: 2019-11-15
• Last updated: 2025-04-03
• Results posted: 2023-11-24

Locations

84 sites across 11 countries: United States, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study