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Phase II study of cabozantinib in patients with metastatic gastrointestinal stromal tumor (GIST) who progressed during neoadjuvant, adjuvant or palliative therapy with imatinib and sunitinib

Study documentation Publications

Trial Status Closed to Patient Entry
Dates Date of activation: 02-Feb-2017
Date Step1 close: 31-Aug-2018
Data management at EORTC Yes
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 50 - All Groups: 50
Treatment Drug
Study Staff Patrick Schoeffski (Study Coordinator) , U.Z. Leuven - Campus Gasthuisberg, Leuven
Catherine Hermans (Data Manager) , EORTC Headquarters, Brussels
Saskia Litiere (Statistician) , EORTC Headquarters, Brussels
Hafida Lmalem (Data Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Axelle Nzokirantevye (Data Manager) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Ionela Stanciu (Clinical Operations Manager) , EORTC Headquarters, Brussels
Xiao Mang Zhou (Junior RAM) , EORTC Headquarters, Brussels
Type of cancer Soft Tissue and Bone Sarcoma
Participating groups EORTC Soft Tissue and Bone Sarcoma Group
Recruiting centers Centre Leon Berard (Lyon, France)
Clatterbridge Cancer Center - Wirral (Wirral, United Kingdom)
Institut Bergonie (Bordeaux, France)
Military Hospital - State Health Centre (Budapest, Hungary)
Royal Marsden Hospital - Chelsea, London (London, United Kingdom)
U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium)
UniversitaetsMedizin Mannheim (Mannheim, Germany)
University College Hospital (London, United Kingdom)
University Hospital Motol (Prague, Czech Republic)
Protocol summary
NCT number NCT02216578
EudraCT 2014-000501-13
Financial Support Educational Grant