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

Official Title

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

Summary:

Study AG881-C-004 is a phase 3, multicentre, 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.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS)

• Time to Next Intervention
• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Tumour Growth Rate as Assessed by Volume per the Blinded Independent Review Committee (BIRC)
• Objective Response as Assessed per the BIRC and Investigator
• Complete Response (CR) + Partial Response (PR) with Response Assessed per the BIRC and Investigator
• Time to Response with Response Assessed per the BIRC and Investigator
• Time to CR + PR with Response Assessed per the BIRC and Investigator
• Duration of Response with Response Assessed per the BIRC and Investigator
• Duration of CR + PR with Response Assessed per the BIRC and Investigator
• Overall Survival
• Health-Related Quality of Life as Measured by Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br)
• Progression-Free Survival (PFS) as Assessed by the Investigator
• Pharmacokinetics: Plasma Concentrations of Vorasidenib Collected at Specified Time Points
• Pharmacokinetics: Plasma Concentrations of Metabolite, AGI-69460, Collected at Specified Time Points

View this trial on ClinicalTrials.gov