SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Glioma, Astrocytoma, Grade IV, IDH1-mutant Glioma, Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4, Astrocytoma, IDH-Mutant, Grade 2, Oligodendroglioma, Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted
In brief
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.
Key facts
- Study ID
- NCT05303519
- Run by
- Nuvation Bio Inc.
- People needed
- 365
- Starts
- 2023-06-05
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama — Birmingham, Alabama, United States (enrolling)
- Columbia University Medical Center — New York, New York, United States (enrolling)
- Mayo Clinic - Arizona — Phoenix, Arizona, United States (enrolling)
- University of California, Los Angeles — Los Angeles, California, United States (enrolling)
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (enrolling)
- University of California — San Francisco, California, United States (enrolling)
- University of Colorado Health Cancer Care — Aurora, Colorado, United States (enrolling)
- Yale University — New Haven, Connecticut, United States (enrolling)
- University of Florida Health — Gainesville, Florida, United States (enrolling)
- Mayo Clinic - Florida — Jacksonville, Florida, United States (enrolling)
- University of Miami Health — Miami, Florida, United States (enrolling)
- Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- Indiana University — Indianapolis, Indiana, United States (enrolling)
- University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- Billings Clinic — Billings, Montana, United States (enrolling)
- Rutgers Cancer Institute — New Brunswick, New Jersey, United States (enrolling)
- NYU Langone Health — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.