Study of 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 AG-881 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 366 participants are planned to be randomized 1:1 to receive orally administered AG-881 40 mg QD or placebo.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS)

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Tumour Growth Rate as Assessed by Volume
• Time to Next Intervention
• Objective Response Rate
• Time to Response
• Duration of Response
• 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
• Maximum Observed Serum Concentration (Cmax) of AG-881
• Area Under Concentration Time Curve from Time 0 to Tau (AUC0-tau) of AG-881
• Time to Reach Maximum Serum Concentration (Tmax) of AG-881

View this trial on ClinicalTrials.gov