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Brief Title: A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
Official Title: A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib
Study ID: NCT03673501
Brief Summary: This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
University of California San Diego Medical Center, La Jolla, California, United States
UCLA Hematology Oncology Center - Main Site, Los Angeles, California, United States
Stanford Medicine, Stanford, California, United States
University of Colorado Hospital - Anschutz Cancer Pavillion, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Smilow Cancer Hospital at Yale, New Haven, Connecticut, United States
Washington Cancer Institute at MedStar Washington Hospital Center, Washington, District of Columbia, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States
Orlando Health UF Health Cancer Center, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Georgia Cancer Specialists, Sandy Springs, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
IU Simon Cancer Center, Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics, Iowa City, Iowa, United States
Norton Cancer Institute, Audubon Hospital Campus, Louisville, Kentucky, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Rutgers Cancer Institute, New Brunswick, New Jersey, United States
Montefiore Medical Center-Montefiore Medical Park, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
The Monter Cancer Center, Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States
University of Toledo, Toledo, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oregon Health & Science University Center for Health and Healing, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Henry-Joyce Cancer Clinic, Nashville, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
University of Washington Medical Center, Seattle, Washington, United States
Froedtert Hospital-Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Sanatorio Allende, Córdoba, Cordoba, Argentina
Instituto Medicao Especializado Alexander Fleming, Buenos Aires, , Argentina
Border Medical Oncology Research Unit, Albury, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
Ashford Cancer Centre Research, Kurralta Park, South Australia, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Princess Alexandara Hospital, Woolloongabba, , Australia
Institut Jules Bordet, Bruxelles, , Belgium
UZ Leuven, Leuven, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont, Québec, , Canada
Clinica San Carlos de Apoquindo Red Salud UC Christs, Santiago, , Chile
Fakultni nemocnice v Motole, Prague, , Czechia
Institut Bergonnié, Bordeaux, , France
Centre Georges François Leclerc, Dijon, , France
Centre Oscar Lambret, Lille Cedex, , France
Centre Léon Bérard, Lyon, , France
Hopital La Timone, Marseille, , France
IPC, Marseille, , France
IGR, Paris, , France
CHU Poitiers-Hopital la Miletrie, Poitiers, , France
ICO - Site René Gauducheau, Saint Herblain, , France
HELIOS Klinikum Berlin-Buch, Berlin, , Germany
Technische Universitat Dresden, Dresden, , Germany
West German Cancer Center, Essen, , Germany
Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, , Hungary
Debreceni Egyetem, Debrecen, , Hungary
Shamir Medical Center (Assaf Harofeh), Be'er Ya'akov, , Israel
Rabin Medical Cente, Petah Tikva, , Israel
Tel-Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, , Italy
stituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
IOV - Istituto Oncologico Veneto IRCCS, Padova, , Italy
Universita degli Studi di Palermo, Palermo, , Italy
Università Campus Bio-Medico di Roma, Rome, , Italy
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
Antoni van Leeuwenhoek, Amsterdam, , Netherlands
The Netherlands Cancer Institute, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Leiden University Medical Centre, Leiden, , Netherlands
Oslo University Hospital, Oslo, , Norway
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie, Warsaw, , Poland
National Cancer Centre, Singapore, , Singapore
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital de Basurto, Bilbao, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Clinico San Carlos, Madrid, , Spain
Hospital Universitario HM Madrid Sanchinarro, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria, Malaga, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Instituto Valenciano de Oncología,, Valencia, , Spain
Complejo Hospitalario Universitario de Vigo, Vigo, , Spain
Karolinska universitetssjukhuset, Solna, , Sweden
Centre Hospitalier Universitaire Vaudois, Fondation du Centre Pluridisciplinaire d'Oncologi, Lausanne, , Switzerland
Universitaetsspital Zuerich, Klinik fuer Onkologie, Zurich, , Switzerland
Chang Gung Memorial Hospital, Linkou, Taoyuan County, Taiwan
Kaohsiung Chang Gung Memorial Hospital,, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Chen Kung University Hospital, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
St James's University Hospital, Leeds, , United Kingdom
Royal Marsden Hospital - Fulham, London, , United Kingdom
University College London Hospitals, London, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom