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

Description

The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue. Part 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study. Part 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse. The study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma

Conditions

Advanced Soft-tissue Sarcoma, Advanced Epithelioid Sarcoma

Study Overview

Study Details

Study overview

The participants of this study will have advanced epithelioid sarcoma. Sarcoma is a cancer of the connective tissues, such as nerves, muscles and bones. Epithelioid sarcoma is an ultra-rare sarcoma of the soft-tissue. Part 1 of this trial will evaluate the safety and the level of the study drug that the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for the next part of the study. Part 2 will evaluate and compare for each of the study drug combinations how long participants live without their disease getting worse. The study drug is called tazemetostat. The study will test tazemetostat in combination with doxorubicin compared to placebo (dummy treatment) in combination with doxorubicin. Doxorubicin is a current front line treatment for epithelioid sarcoma

A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma

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

Condition
Advanced Soft-tissue Sarcoma
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Comprehensive Cancer Center, Duarte, California, United States, 91010

Santa Monica

Sarcoma Oncology Research Center, Santa Monica, California, United States, 90403

Aurora

University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States, 80045

Denver

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218

Jacksonville

Mayo Clinic-Jacksonville, Jacksonville, Florida, United States, 32224

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02214

Boston

Dana Farber Cancer Insititute, Boston, Massachusetts, United States, 02215

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Ann Arbor

University of Michigan Medical Center, Ann Arbor, Michigan, United States, 48109

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Epizyme, Inc.,

    Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

    Study Record Dates

    2030-01-01