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SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
NCT05303519 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG safusidenib
Study Locations (20)
California
- University of California, Los Angeles — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
- Stanford University — Palo Alto
- University of California — San Francisco
Florida
- University of Florida Health — Gainesville
- Mayo Clinic - Florida — Jacksonville
- University of Miami Health — Miami
- Orlando Health Cancer Institute — Orlando
Arizona
- Mayo Clinic - Arizona — Phoenix
- St. Joseph's Hospital and Medical Center — Phoenix
Massachusetts
- Massachusetts General Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Alabama
- University of Alabama — Birmingham
Colorado
- University of Colorado Health Cancer Care — Aurora
Connecticut
- Yale University — New Haven
Kansas
- University of Kansas Medical Center — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2030-12-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05303519
The ClinicalTrials.gov registry entry for NCT05303519 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 365 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nuvation Bio, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Glioma appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05303519 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05303519 about?
NCT05303519 is a clinical study titled "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 ...
What is the current status of trial NCT05303519?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 365 participants. The study started on 2023-06-05. Estimated completion is 2030-12-01.
What conditions does trial NCT05303519 study?
This clinical trial studies the following conditions: Glioma, Oligodendroglioma, Astrocytoma, Grade IV, Astrocytoma, IDH-Mutant, Grade 2, IDH1-mutant Glioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05303519?
The interventions under investigation include: Placebo (DRUG), safusidenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05303519?
This trial is sponsored by Nuvation Bio, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05303519 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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