SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance) (NCT05303519)
A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (61 Sites)
Showing the first 25 of 61 sites.
- University of Alabama — Birmingham, Alabama
- Mayo Clinic - Arizona — Phoenix, Arizona
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona
- University of California San Diego — La Jolla, California
- University of California, Los Angeles — Los Angeles, California
- Hoag Memorial Hospital Presbyterian — Newport Beach, California
- Stanford University — Palo Alto, California
- University of California — San Francisco, California
- University of Colorado Health Cancer Care — Aurora, Colorado
- Yale University — New Haven, Connecticut
- University of Florida Health — Gainesville, Florida
- Mayo Clinic - Florida — Jacksonville, Florida
- University of Miami Health — Miami, Florida
- Orlando Health Cancer Institute — Orlando, Florida
- Emory University — Atlanta, Georgia
- University of Chicago — Chicago, Illinois
- Indiana University — Indianapolis, Indiana
- University of Kansas Medical Center — Kansas City, Kansas
- University of Kentucky — Lexington, Kentucky
- Massachusetts General Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Henry Ford Hospital — Detroit, Michigan
- Mayo Clinic - Rochester — Rochester, Minnesota
- Washington University — St Louis, Missouri
- Billings Clinic — Billings, Montana
📞 Contact the Study Coordinator
Phone: (332) 208-6102
Email: ClinicalTrials@nuvationbio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma — Los Angeles, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.