Spots Global Cancer Trial Database for Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
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Trial Identification
Brief Title: Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Crenolanib in Subjects With Advanced or Metastatic Gastrointestinal Stromal Tumors With a D842V Mutation in the PDGFRA Gene
Study ID: NCT02847429
Conditions
Study Description
Brief Summary: This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sarcoma Oncology Center, Santa Monica, California, United States
University of Miami, Miami, Florida, United States
Duke Cancer Institute, Durham, North Carolina, United States
Oregon Health and Science University, Portland, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Institut Bergonie, Bordeaux, , France
Centre Leon Berard, Lyon, , France
La Timone University Hospital, Marseille, , France
Centre Hospitalier Universitaire (CHU) de Reims, Reims, , France
HELIOS Klinikum Berlin-Buch, Berlin, , Germany
Mannheim University Medical Centre, University of Heidelberg, Mannheim, , Germany
Universitätsklinikum München, Munich, , Germany
Policlinico S. Orsola-Malpighi, Bologna, , Italy
Istituto Nazionale Tumori, Milan, , Italy
Institut Regina Elena / IFO, Rome, , Italy
Candiolo Cancer Institute - FPO, IRCCS, Turin, , Italy
University Hospital The Norwegian Radium Hospital, Oslo, , Norway
M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, , Poland
Vall d'Hebron University Hospital, Barcelona, , Spain
Hospital Universitario Puerta de Hierro, Madrid, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Fundación Instituto Valenciano de Oncología, Valencia, , Spain
Contact Details
Name: Jean-Yves Blay, MD
Affiliation: Centre Leon Berard
Role: PRINCIPAL_INVESTIGATOR
Name: Margaret von Mehren, MD
Affiliation: Fox Chase Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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