EORTC-1317-STBSG

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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

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 Cabozantinib
Study Staff	Patrick Schoeffski (Study Coordinator) , U.Z. Leuven - Campus Gasthuisberg, Leuven Saskia Litiere (Statistician) , EORTC Headquarters, Brussels Hafida Lmalem (Data Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Zara Nasir (Pharmacovigilance Manager) , 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	http://clinicaltrials.gov/study/NCT02216578
NCT number	NCT02216578
EudraCT	2014-000501-13
Financial Support	Educational Grant