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Brief Title: Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients With Advanced Angiosarcoma
Official Title: A Randomized Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients With Advanced Angiosarcoma (TAPPAS)
Study ID: NCT02979899
Brief Summary: This is a study of TRC105 in combination with standard dose pazopanib compared to single agent pazopanib in patients with angiosarcoma not amenable to curative intent surgery (e.g., metastatic or bulky disease, and disease for which surgical resection would carry an unacceptable risk to the patient) who have not received pazopanib or TRC105 previously.
Detailed Description: TRC105 (carotuximab) is a monoclonal antibody to endoglin (CD105), an essential angiogenic target highly expressed on tumor vessels that is distinct from VEGFR. Endoglin is also expressed directly on tumor cells in angiosarcoma and is upregulated following VEGF inhibition. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models and complements the activity of bevacizumab and multi-kinase inhibitors that target the VEGFR. Pazopanib is an oral inhibitor of multiple receptor tyrosine kinases, including vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, and VEGFR-3 at therapeutic plasma concentrations. These receptors are implicated in pathologic angiogenesis, tumor growth, and cancer progression. By targeting a non-VEGF pathway that is upregulated following VEGF inhibition, TRC105 has the potential to complement VEGFR tyrosine kinase inhibitors (TKIs) and could represent a major advance in the treatment of angiosarcoma. Together, the use of TRC105 with pazopanib may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with pazopanib alone.
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona Cancer Center, Tucson, Arizona, United States
Stanford University, Palo Alto, California, United States
Sarcoma Oncology Center, Santa Monica, California, United States
University of Colorado Denver, Aurora, Colorado, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northside Hospital, Sandy Springs, Georgia, United States
University of Iowa, Iowa City, Iowa, United States
Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University St. Louis, Saint Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Northwell Health, Lake Success, New York, United States
MSKCC, New York, New York, United States
Duke University, Durham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
UPMC, Pittsburgh, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
MD Anderson, Houston, Texas, United States
University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Washinton, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Medical University,Vienna, Wien, , Austria
Institut Bergonié, Bordeaux, , France
Centre Oscar Lambret, Lille, , France
Centre Léon Bérard, Lyon, , France
Institut Gustave Roussy, Villejuif, , France
Helios Klinikum, Bad Saarow, , Germany
Mannheim University Medical Center, Mannheim, , Germany
Klinikum derUniversitat Munchen, Munich, , Germany
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Memorial Cancer Center and Institute of Oncology, Warszawa, , Poland
Institut Català d'Oncologia (ICO), Barcelona, , Spain
12 de Octubre University Hospital, Madrid, , Spain
Royal Marsden NHS, Chelsea, , United Kingdom
Name: Charles Theuer, MD
Affiliation: TRACON Pharmaceuticals
Role: STUDY_DIRECTOR