Spots Global Cancer Trial Database for A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
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Trial Identification
Brief Title: A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib
Official Title: An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated With Imatinib
Study ID: NCT05734105
Conditions
Study Description
Brief Summary: This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC San Diego Moores Cancer Center, La Jolla, California, United States
Yale University, New Haven, Connecticut, United States
Mayo Clinic Florida, Jacksonville, Florida, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
M Health Fairview University of Minnesota Medical Center, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Northwell Health Cancer Institute/ R.J. Zuckerberg Cancer Center, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oregon Health & Science University, Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Alfred Health, Melbourne, Victoria, Australia
CEPEN - Centro de Pesquisa e Ensino em Saude de Santa Catarina, Florianópolis, Santa Catarina, Brazil
Hospital de Cancer de Barretos - Fundacao Pio XII, Barretos, Sao Paulo, Brazil
Hospital Sirio-Libanes, São Paulo, Sao Paulo, Brazil
Hospital 9 de Julho, São Paulo, SP, Brazil
INCA - Instituto Nacional de Cancer, Rio De Janeiro, , Brazil
AC Camargo Câncer Center, São Paulo, , Brazil
Juravinski Cancer Centre, Hamilton, Ontario, Canada
University Health Network, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
McGill University Health Centre, Montréal, Quebec, Canada
Clínica San Carlos De Apoquindo Red Salud UC Christus, Las Condes, RM, Chile
Centre Léon Bérard, Lyon, , France
Institut Gustave Roussy, Villejuif, , France
Helios Klinikum Berlin-Buch, Berlin, , Germany
Istituto Nazionale Tumori IRCCS Fondazione "G Pascale", Naples, Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, , Italy
Istituto Oncologico Veneto-IOV IRCCS, Padova, , Italy
U.O.C. Oncologia Medica, Palermo, , Italy
Università Campus Bio-Medico di Roma, Roma, , Italy
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
UMC Groningen, Groningen, , Netherlands
LUMC, Leiden, , Netherlands
Narodowy Instytut Onkologii Im . Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw, Warszawa, Poland
Complejo Hospitalario Universitario de Vigo - Hospital Alvaro Cunqueiro, Vigo, Pontevedra, Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Instituto Valenciano de Oncologia - IVO, Valencia, , Spain
China Medical University Hospital, Taichung, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
The Royal Marsden Hospital NHS Foundation Trust, London, Greater London, United Kingdom
St. James University Hospital, Leeds, West Yorkshire, United Kingdom
Contact Details
Name: Clinical Team
Affiliation: Deciphera Pharmaceuticals LLC
Role: STUDY_DIRECTOR
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