RECRUITING

SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

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Conditions

GliomaAstrocytoma, Grade IVIDH1-mutant GliomaAstrocytoma, IDH-Mutant, Grade 3Astrocytoma, IDH-Mutant, Grade 4Astrocytoma, IDH-Mutant, Grade 2OligodendrogliomaOligodendroglioma, IDH-Mutant and 1p/19q-Codeletedsafusidenibastrocytoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-06-05
Study Completion:2030-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05303519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trials at Nuvation Bio
CONTACT
332-208-6102
ClinicalTrials@nuvationbio.com

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35294
United States
Mayo Clinic - Arizona
Phoenix, Arizona, 85013
United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States
University of California, Los Angeles
Los Angeles, California, 90095
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
Stanford University
Palo Alto, California, 94304
United States
University of California
San Francisco, California, 94143
United States
University of Colorado Health Cancer Care
Aurora, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06510
United States
University of Florida Health
Gainesville, Florida, 32608
United States
Mayo Clinic - Florida
Jacksonville, Florida, 32224
United States
University of Miami Health
Miami, Florida, 33136
United States
Orlando Health Cancer Institute
Orlando, Florida, 32806
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Massachusetts General Hospital
Boston, Massachusetts, 02214
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Washington University
St Louis, Missouri, 63110
United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
United States
NYU Langone Health
New York, New York, 10016
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke Cancer Institute
Durham, North Carolina, 27710
United States
Cleveland Clinic
Cleveland, Ohio, 44106
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Huntsman Cancer Insititute, University of Utah
Salt Lake City, Utah, 84112
United States
UVA Health, Emily Couric Clinical Cancer Cente
Charlottesville, Virginia, 22903
United States
Fred Hutch Cancer Center
Seattle, Washington, 98195
United States
University of Wisconsin Health
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Nuvation Bio Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-05
Study Completion Date2030-12-01

Study Record Updates

Study Start Date2023-06-05
Study Completion Date2030-12-01

Terms related to this study

Keywords Provided by Researchers

  • safusidenib
  • IDH1-mutant glioma
  • astrocytoma

Additional Relevant MeSH Terms

  • 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