Last updated on February 2018

Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma

Brief description of study

This is a Phase 2, multicenter, open-label, 2-part, single-arm, 2-stage study of tazemetostat 800 mg two times a day (BID) administered orally. Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat. In Part 1, 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status will be treated and undergo pharmacokinetics (PK) blood sample collection after a single tazemetostat 800 mg. Part 2 will include subjects with BAP1-deficient relapsed or refractory malignant mesothelioma. 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 6 weeks of treatment and then every 12 weeks thereafter while on study.

Clinical Study Identifier: NCT02860286

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Robert Cameron, MD

University of California, Los Angeles
Los Angeles, CA United States

Marianna Koczywas, MD

City of Hope National Medical Center
Los Angeles, CA United States

Thierry Jahan, MD

University of California San Francisco
San Francisco, CA United States

Petr Hausner, MD

University of Maryland Medical Center
Baltimore, MD United States

Christopher Azzoli, MD

Massachusetts General Hospital
Boston, MA United States

David Jackman, MD

Dana-Farber Cancer Institute
Boston, MA United States

Tobias Peikert, MD

Mayo Clinic - Rochester
Rochester, MN United States

Marjorie Zauderer, MD

Memorial Sloan Kettering Cancer Center
New York, NY United States

Anne Tsao, MD

MD Anderson Cancer Center
Houston, TX United States

Sylvestre Le Moulec, MD

Institut Bergonie
Bordeaux Cedex, France

Arnaud Scherpereel, MD

CHRU de Lille
Lille, France

David Planchard, MD

Institut Gustave Roussy
Villejuif cedex, France

Paul Taylor, MD

University Hospital of South Manchester
Greater Manchester, United Kingdom

Dean Fennel, MD

University of Leicester & Leicester University Hospitals
Leicester, United Kingdom

Peter Szlosarek, MD

St. Bartholomew's Hospital
London, United Kingdom

Martin Forster, MD

University College Hospital
London, United Kingdom

Sanjay Popat, MD

Royal Marsden Hospital - Chelsea
London, United Kingdom

Sanjay Popat, MD

Royal Marsden Hospital - Surrey
Surrey, United Kingdom