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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation, Astrocytoma IDH Mutant Grade 2, Oligodendroglioma, Oligodendroglioma IDH-mutant and 1p/19q-codeleted, IDH-mutant Gliomas

In brief

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.

Key facts

Study ID

NCT07712757

Run by

Nuvation Bio Inc.

People needed

140

Starts

2027-03-01

Expected to finish

2032-03-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Full record on ClinicalTrials.gov

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