Spots Global Cancer Trial Database for Study of Vimseltinib for Tenosynovial Giant Cell Tumor
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Trial Identification
Brief Title: Study of Vimseltinib for Tenosynovial Giant Cell Tumor
Official Title: A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients With Tenosynovial Giant Cell Tumor (MOTION)
Study ID: NCT05059262
Study Description
Brief Summary: This is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
University of Colorado, Aurora, Colorado, United States
University of Kansas, Kansas City, Kansas, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Duke Sarcoma Research, Durham, North Carolina, United States
Ohio State University, Columbus, Ohio, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Chris O'Brien Lifehouse, Camperdown, , Australia
McGill University, Montréal, , Canada
Princess Margaret Hospital, Toronto, , Canada
Institut Bergonié, Bordeaux, , France
Centre Léon Bérard, Lyon, , France
Institut Gustave Roussy, Villejuif, , France
Helios Klinikum Berlin-Buch, Berlin, , Germany
University Hospital Essen (Universitätsklinikum Essen), Essen, , Germany
Prince of Wales Hospital, Hong Kong, , Hong Kong
Istituto Ortopedico Rizzoli, Bologna, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Naples, , Italy
Istituto Oncologico Veneto, Padua, , Italy
Istituto Nazionale Tumori Regina Elena, Rome, , Italy
Leiden University Medical Center, Leiden, , Netherlands
Oslo University Hospital, Oslo, , Norway
Klinika Nowotworów Tkanek Miękkich, Kości i Czerniaków Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw, , Poland
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Universitäts-Kinderspital beider Basel (UKBB), Basel, , Switzerland
Cancer & Haematology Centre, The Churchill Hospital - Oxford University Hospitals NHS Foundation Trust, London, , United Kingdom
University College London Hospitals, London, , United Kingdom
Contact Details
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