Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted

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Review clinical trials related to Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

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.

Participants needed: 365
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Nuvation Bio Inc.Updated: Jul 1, 2026Locations: 57
Eligibility criteria

Patient must be ≥ 18 years of age at the time of signing the informed consent fo... [+16]

Systemic drug therapies: within 3 weeks (lomustine within 6 weeks) [+13]