Last updated on March 2018

A Phase II Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

Brief description of study

This is a Phase II, multicenter, open-label, single arm, 2-stage study of tazemetostat 800 mg BID administered orally in continuous 28 day cycles. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat. Eligible subjects will be enrolled into one of fivecohorts based on tumor type:

  • Cohort 1 (Closed for enrollment): MRT, RTK, ATRT, or selected tumors with rhabdoid features, including small cell carcinoma of the ovary hypercalcemic type [SCCOHT], also known as malignant rhaboid tumor of the ovary [MRTO]
  • Cohort 2 (Closed for enrollment): Relapsed or refractory synovial sarcoma with SS18-SSX rearrangement
  • Cohort 3 (Closed for enrollment): Other INI1 negative tumors or any solid tumor with an EZH2 gain of function (GOF) mutation, including: epithelioid malignant peripheral nerve sheath tumor (EMPNST), extraskeletal myxoid chondrosarcoma (EMC), myoepithelial carcinoma, other INI1-negative malignant tumors with Sponsor approval (e.g., dedifferentiated chordoma) any solid tumor with an EZH2 GOF mutation including but not limited to Ewing's sarcoma and melanoma
  • Cohort 4 (Closed for enrollment): Renal medullary carcinoma (RMC)
  • Cohort 5 (Closed for enrollment): Epithelioid sarcoma (ES)
  • Cohort 6 (Opened for enrollment): Epithelioid sarcoma (ES) undergoing mandatory tumor biopsy
  • Cohort 7 (Opened for enrollment): Poorly differentiated chordoma (or other chordoma with Sponsor approval)

Treatment with tazemetostat will continue until disease progression, unacceptable toxicity or withdrawal of consent, or termination of the study. Response assessment will be evaluated after 8 weeks of treatment and then every 8 weeks thereafter while on study.

Clinical Study Identifier: NCT02601950

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Thierry Jahan, MD

University of California San Francisco
San Francisco, CA United States
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Victor Villalobos, MD

University of Colorado Denver
Aurora, CO United States
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Steven Attia, MD

Mayo Clinic - Jacksonville
Jacksonville, FL United States
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Mark Agulnik, MD

Northwestern Memorial Hospital
Chicago, IL United States
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Greg Cote, MD

Massachusetts General Hospital - Cancer Center
Boston, MA United States
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George Demetri, MD

Dana Farber Cancer Institute
Boston, MA United States
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Rashmi Chugh, MD

University of Michigan
Ann Arbor, MI United States
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B Van Tine, MD

Washington University
Saint Louis, MO United States
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Mrinal Gounder, MD

Memorial Sloan Kettering Cancer Center
New York, NY United States
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Joseph Pressey, MD

Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Lara Davis, MD

Oregon Health Sciences University
Portland, OR United States
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Nizar Tannir, MD

MD Anderson Cancer Center
Houston, TX United States
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Maria Roche, NP

Seattle Children's Hospital
Seattle, WA United States
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Elizabeth Loggers, MD

Fred Hutchinson Cancer Research Center
Seattle, WA United States
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David Thomas, MD

Chris O'Brien Lifehouse
Camperdown, Australia
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Warren Joubert, MD

Metro South Hospital and Health Service via Princess Alexandra Hospital
Woolloongabba, Australia
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Thierry Gil, MD

Institut Jules Bordet Medical Oncology Clinic
Brussels, Belgium
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Patrick Schoffski, MD

University Hospital Leuven
Leuven, Belgium
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Quincy Chu, MD

Alberta Health Services
Edmonton, AB Canada
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Abha Gupta, MD

Princess Margaret Hospital
Toronto, ON Canada
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Thierry Alcindor, MD

McGill University Health Centre - Royal Victoria Hospital
Montreal, QC Canada
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Antoine Italiano, MD

Institut Bergonie
Bordeaux, France
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Jean-Yves Blay, MD

Centre Leon Berard
Lyon, France
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Maria Roche, NP

Hospital Pitie Salpetriere
Paris Cedex 13, France
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Valerie Laurence, MD

Institut Curie
Paris, France
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Olivier Mir, MD

Institut Gustave Roussy
Villejuif, France
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Bjoern Hackanson, MD

Children's Hospital Augsburg Klinikum
Augsburg, Germany
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Peter Reichardt, MD

Sarcoma Center HELIOS Klinikum Berlin
Berlin, Germany
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Silvia Stacchiotti, MD

Instituto Nazionale Tumori - National Cancer Institute Via Giacomo Venezian
Milano, Italy
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Wei-Wu Chen, MD

National Taiwan University Hospital
Taipei City, Taiwan
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Palma Dileo, MD

London Sarcoma Service Department of Oncology
London, United Kingdom
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Robin Jones, MD

Royal Marsden Foundation Trust
London, United Kingdom
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