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Recruiting Phase 3 Interventional

SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

ClinicalTrials.gov ID: NCT05303519

Public ClinicalTrials.gov record NCT05303519. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05303519
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Nuvation Bio Inc.
Industry
Enrollment
365 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 4, 2023
Primary completion
Nov 30, 2028
Completion
Nov 30, 2030
Last update posted
Aug 27, 2026

2023 – 2030

United States locations

U.S. sites
46
U.S. states
28
U.S. cities
41
Facility City State ZIP Site status
University of Alabama Birmingham Alabama 35294 Recruiting
Mayo Clinic - Arizona Phoenix Arizona 85013 Recruiting
St. Joseph's Hospital and Medical Center Phoenix Arizona 85013 Recruiting
University of California San Diego La Jolla California 92093 Recruiting
University of California, Los Angeles Los Angeles California 90095 Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California 92663 Recruiting
Stanford University Palo Alto California 94304 Recruiting
University of California San Francisco California 94143 Recruiting
University of Colorado Health Cancer Care Aurora Colorado 80045 Recruiting
Yale University New Haven Connecticut 06510 Recruiting
University of Florida Health Gainesville Florida 32608 Recruiting
Mayo Clinic - Florida Jacksonville Florida 32224 Recruiting
University of Miami Health Miami Florida 33136 Recruiting
Orlando Health Cancer Institute Orlando Florida 32806 Recruiting
Emory University Atlanta Georgia 30322 Recruiting
University of Chicago Chicago Illinois 60637 Not yet recruiting
Indiana University Indianapolis Indiana 46202 Recruiting
University of Kansas Medical Center Kansas City Kansas 66160 Recruiting
University of Kentucky Lexington Kentucky 40536 Recruiting
Massachusetts General Hospital Boston Massachusetts 02214 Recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Recruiting
Henry Ford Hospital Detroit Michigan 48202 Recruiting
Mayo Clinic - Rochester Rochester Minnesota 55905 Recruiting
Washington University St Louis Missouri 63110 Recruiting
Billings Clinic Billings Montana 59101 Recruiting
Rutgers Cancer Institute New Brunswick New Jersey 08901 Recruiting
NYU Langone Health New York New York 10016 Recruiting
Icahn School of Medicine at Mount Sinai New York New York 10029 Not yet recruiting
Columbia University Medical Center New York New York 10032 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
University of Rochester Medical Center Rochester New York 14642 Recruiting
Duke Cancer Institute Durham North Carolina 27710 Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina 27157 Not yet recruiting
Cleveland Clinic Cleveland Ohio 44106 Recruiting
Oregon Health Science University Portland Oregon 97239 Recruiting
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania 15232 Recruiting
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37203 Recruiting
University of Texas Southwestern Medical Center Dallas Texas 75390 Recruiting
MD Anderson Cancer Center Houston Texas 77030 Recruiting
University of Texas Health Mays Cancer Center San Antonio Texas 78229 Recruiting
Huntsman Cancer Insititute, University of Utah Salt Lake City Utah 84112 Recruiting
UVA Health, Emily Couric Clinical Cancer Cente Charlottesville Virginia 22903 Recruiting
Inova Schar Cancer Institute Fairfax Virginia 22031 Recruiting
Fred Hutch Cancer Center Seattle Washington 98195 Recruiting
University of Wisconsin Health Madison Wisconsin 53792 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05303519, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05303519 live on ClinicalTrials.gov.

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