TERMINATED

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

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

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

Official Title

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

Quick Facts

Study Start:2019-12-19
Study Completion:2024-06-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04204941

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

Principal Investigator

Ipsen Medical Director
STUDY_DIRECTOR
Ipsen

Study Locations (Sites)

City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
Sarcoma Oncology Research Center
Santa Monica, California, 90403
United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224
United States
Massachusetts General Hospital
Boston, Massachusetts, 02214
United States
Dana Farber Cancer Insititute
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
United States
Washington University
Saint Louis, Missouri, 63110
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37203
United States
Fred Hutchinson Research Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Epizyme, Inc.

  • Ipsen Medical Director, STUDY_DIRECTOR, Ipsen

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 Date2019-12-19
Study Completion Date2024-06-14

Study Record Updates

Study Start Date2019-12-19
Study Completion Date2024-06-14

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Soft-tissue Sarcoma
  • Advanced Epithelioid Sarcoma