Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma

PHASE3TerminatedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 19, 2019

Primary Completion Date

June 14, 2024

Study Completion Date

June 14, 2024

Conditions
Advanced Soft-tissue SarcomaAdvanced Epithelioid Sarcoma
Interventions
DRUG

Tazemetostat

400 mg, 600 to 800 mg of Tazemetostat will be administered twice daily.

DRUG

Doxorubicin HCl

75mg/m2 intravenous injection day 1 of each cycle for up to 6 cycles

DRUG

Tazemetostat

800 mg administered orally twice daily in continuous 21-day cycles during cycles 1-6 and in continuous 28-day cycles during cycle 7 and beyond.

DRUG

Placebo

Placebo administered orally twice daily in continuous 21-day cycles during cycles 1-6 and in continuous 28-day cycles during cycles 7 and beyond

DRUG

Doxorubicin HCl

75mg/m2 intravenous injection day 1 of each cycle for up to 6 cycles

Trial Locations (21)

100

National Taiwan University Hospital, Taipei

10032

Columbia University Irving Medical Center, New York

15232

University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh

19107

Thomas Jefferson University Hospital, Philadelphia

27710

Duke University Medical Center, Durham

32224

Mayo Clinic-Jacksonville, Jacksonville

37203

Sarah Cannon and HCA Research Institute, Nashville

43210

The Ohio State University Comprehensive Cancer Center, Columbus

48109

University of Michigan Medical Center, Ann Arbor

63110

Washington University, St Louis

80045

University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora

80218

Sarah Cannon Research Institute at HealthONE, Denver

90403

Sarcoma Oncology Research Center, Santa Monica

91010

City of Hope Comprehensive Cancer Center, Duarte

97239

Oregon Health and Science University, Portland

98109

Fred Hutchinson Research Center, Seattle

02214

Massachusetts General Hospital, Boston

02215

Dana Farber Cancer Insititute, Boston

Dana Farber Cancer Institute, Boston

H4A 3J1

McGill University Faculty of Medicine - Royal Victoria Hospital, Montreal

SW3 6JJ

Royal Marsden Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Epizyme, Inc.

INDUSTRY

NCT04204941 - Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma | Biotech Hunter | Biotech Hunter