HomeTrialNCT05303519
🔬NCT05303519Phase 3RECRUITING

SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

Study Summary

This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.

Interventions / Drugs
View on ClinicalTrials.gov ↗
Study Details
Enrollment365 participants
Primary Completion
Lead SponsorNuvation Bio Inc.
Data Retrieved2026-04-11 04:23:06.088384+00:00
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