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Brief Title: (VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
Official Title: An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)
Study ID: NCT03465722
Brief Summary: This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Cancer Center, Phoenix, Arizona, United States
UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Boulder, Colorado, United States
Washington Hospital Center - Oncology and Hematology, Washington, District of Columbia, United States
Mayo Clinic Cancer Center, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Northwestern Medicine, Chicago, Illinois, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Washington University in Saint Louis, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Ohio State University, Columbus, Ohio, United States
OHSU - Knight Cancer Institute, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Tennessee Oncology, Nashville, Tennessee, United States
USO - Texas Oncology, Dallas, Texas, United States
Texas Oncology - Denton South, Denton, Texas, United States
University of Texas MD Anderson, Houston, Texas, United States
Texas Oncology - Waco, Waco, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Summit Cancer Centers, Spokane, Washington, United States
Medical College of Wisconsin - Froedtert Hospital, Milwaukee, Wisconsin, United States
Flinders Medical Center, Adelaide, , Australia
Monash Health, Clayton, , Australia
The Canberra Hospital, Garran, , Australia
AKH, Klinik f. Innere Med. I, Onkologie, Wien, , Austria
Institut Jules Bordet, Brussels, , Belgium
Leuven Cancer Institute, Leuven, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
University Health Network, Toronto, Ontario, Canada
Jewish General Hospital, Montréal, , Canada
Beijing Cancer Hospital, Beijing, , China
Chinese PLA General Hospital, Beijing, , China
West China Hospital Sichuan University, Chengdu, , China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, , China
Fujian Medical University Union Hospital, Fuzhou, , China
The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, , China
The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, , China
The First Affiliated Hospital, Zhejiang University, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
The First Affiliated Hospital of Nanchang Medical University, Nanchang, , China
Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College, Nanning, , China
The Affiliated Hospital of Qingdao University, Qingdao, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Fudan University Zhongshan Hospital, Shanghai, , China
Shanghai Jiaotong University School of Medicine, Renji Hospital, Shanghai, , China
Liaoning Cancer Hospital & Institute, Shenyang, , China
Tianjin Cancer Hospital, Tianjin, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, , China
Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi, , China
Onkologická klinika Fakultní nemocnice Olomouc, Olomouc, , Czechia
Fackultni Nemocnice v Motole, Praha, , Czechia
Institut Bergonié, Bordeaux, , France
Centre Oscar Lambret, Lille, , France
UNICANCER - Lyon, Centre Léon-Bérard, Lyon, , France
Institute Paoli Calmettes, Marseille, , France
La Timone University Hospital, Marseille, , France
Institut Curie, Paris, , France
Centre Rene Gauducheau, Saint-Herblain, , France
Gustave Roussy Cancer Campus, Villejuif, , France
HELIOS Klinikum Bad Saarow, Bad Saarow, , Germany
HELIOS Klinikum Berlin-Buch, Berlin, , Germany
Medizinische Fakultät Carl Gustav Carus, Dresden, , Germany
Universitaetsklindum Essen, Essen, , Germany
Universitätsklinikum Frankfurt, Frankfurt, , Germany
Studienzentrale GbR Lübecker Onkologische Schwerpunktpraxis Dres. med. Uthgenannt, Lubeck, , Germany
Rupercht-Karls-Universitaet Heidelberg, Mannheim, , Germany
Fovarosi Onkormanyzat Szent Laszlo Korhaz, Budapest, , Hungary
Magyar Honvédség Egészségügyi Központ Onkológiai Osztály, Budapest, , Hungary
Medical Oncology University Debrecen, Debrecen, , Hungary
University of Pécs, Pécs, , Hungary
Azienda Ospedaliero Universitaria Sant'Orsola Malpighi, Bologna, , Italy
Candiolo Cancer Institute - FPO, IRCCS, Candiolo, , Italy
AOUC Azienda Ospedaliero - Universitaria Careggi, Firenze, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Universita degli Studi di Palermo - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, , Italy
Campus Bio-Medico - Oncology Medica, Roma, , Italy
Ajou University Hospital, Suwon-si, Gyeong Gi-do, Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Radboud University Medical Center, Nijmegen, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Sanodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie, Oddzial Kliniczny Onkologii, Kraków, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z W-MCO, Olsztyn, , Poland
Maria Skodowska Curie Memorial Cancer Centre and Institute of Oncology, Warszawa, , Poland
Dolnoslaskie Centrum Onkologii we Wrocawiu, Wrocław, , Poland
National Cancer Centre Singapore, Singapore, , Singapore
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Institut Català d'Oncologia - Hospital Duran i Reynals, Barcelona, , Spain
Vall d'Hebron, Barcelona, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Madrid, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Fundacion Instituto Valenciano de Oncologia, Servicio de Oncologia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Skanes University Hospital, Lund, , Sweden
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
Guy's Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom