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NCT05303519 · ClinicalTrials.gov registry record · Phase 3
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
A Phase 3 study of Glioma and Oligodendroglioma, sponsored by Nuvation Bio.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 365
- Enrollment target
- 20
- Study locations
NCT05303519 is a Phase 3 study of Glioma and Oligodendroglioma that is actively recruiting participants, run by Nuvation Bio. The registered enrollment target is 365 participants, above the 206-participant average among 87 other Glioma trials with a reported enrollment target (77% higher). The trial reports 20 study locations across 12 states.
The verdict
NCT05303519, a Phase 3 study of Glioma and Oligodendroglioma, is actively recruiting participants, sponsored by Nuvation Bio.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 365 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 365 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 206-participant average among 87 other Glioma trials with a reported enrollment target (77% higher). The listed sponsor is Nuvation Bio, which has 7 total studies on file at ClinicalTrials.gov.
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.
NCT05303519 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Arizona.
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.
What interventions are being tested in trial NCT05303519?
The interventions under investigation include: Placebo (DRUG), safusidenib (DRUG).
Who is sponsoring clinical trial NCT05303519?
This trial is sponsored by Nuvation Bio, which has 7 total clinical trials registered on ClinicalTrials.gov.
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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Related
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