Safusidenib Phase 2 Study in IDH1 Mutant Glioma

PHASE2RecruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

June 5, 2023

Primary Completion Date

December 1, 2027

Study Completion Date

March 1, 2028

Conditions
GliomaAstrocytoma, Grade IVIDH1-mutant GliomaAstrocytoma, IDH-Mutant, Grade 3Astrocytoma, IDH-Mutant, Grade 4
Interventions
DRUG

safusidenib

safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with agent safusidenib until disease progression or development of other unacceptable toxicity.

DRUG

Placebo

Placebo administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with placebo until disease progression or another reason for discontinuation occurs.

Trial Locations (31)

10016

NOT_YET_RECRUITING

New York University Langone Health, New York

10032

RECRUITING

Columbia University Medical Center, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

22903

RECRUITING

UVA Health, Emily Couric Clinical Cancer Cente, Charlottesville

27710

RECRUITING

Duke Cancer Institute, Durham

32224

NOT_YET_RECRUITING

Mayo Clinic - Florida, Jacksonville

32608

NOT_YET_RECRUITING

University of Florida Health, Gainesville

32806

NOT_YET_RECRUITING

Orlando Health Cancer Institute, Orlando

33136

NOT_YET_RECRUITING

University of Miami Health, Miami

35294

RECRUITING

University of Alabama, Birmingham

44106

RECRUITING

Cleveland Clinic, Cleveland

48202

NOT_YET_RECRUITING

Henry Ford Hospital, Detroit

53792

NOT_YET_RECRUITING

University of Wisconsin Health, Madison

55905

RECRUITING

Mayo Clinic - Rochester, Rochester

63110

NOT_YET_RECRUITING

Washington University, St Louis

66160

NOT_YET_RECRUITING

University of Kansas Medical Center, Kansas City

75390

NOT_YET_RECRUITING

University of Texas Southwestern Medical Center, Dallas

77030

NOT_YET_RECRUITING

MD Anderson Cancer Center, Houston

80045

NOT_YET_RECRUITING

University of Colorado Health Cancer Care, Aurora

84112

RECRUITING

Huntsman Cancer Insititute, University of Utah, Salt Lake City

85013

RECRUITING

Mayo Clinic - Arizona, Phoenix

RECRUITING

St. Joseph's Hospital and Medical Center, Phoenix

90095

NOT_YET_RECRUITING

University of California, Los Angeles, Los Angeles

92663

RECRUITING

Hoag Memorial Hospital Presbyterian, Newport Beach

94143

NOT_YET_RECRUITING

University of California, San Francisco

94304

NOT_YET_RECRUITING

Stanford University, Palo Alto

98195

NOT_YET_RECRUITING

Fred Hutch Cancer Center, Seattle

06510

RECRUITING

Yale University, New Haven

02214

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

08901

RECRUITING

Rutgers Cancer Institute, New Brunswick

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AnHeart Therapeutics Inc.

INDUSTRY

lead

Nuvation Bio Inc.

INDUSTRY