Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or astrocytoma) with an IDH1 mutation who have undergone surgery as their only treatment and are not in need of immediate chemotherapy or radiotherapy.

Timeline

Start

2027-03

Primary completion

2029-05

Completion

2032-03

Drugs

Indications