Clinical Trial Details

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
Laura De Meulemeester (Clinical Operations Manager) laura.demeulemeester (at) eortc.org, EORTC Headquarters, Brussels
Giovanna Farro (Clinical Scientist) giovanna.farro (at) eortc.org, EORTC Headquarters, Brussels
Catherine Hermans (Data Manager) catherine.hermans (at) eortc.org, EORTC Headquarters, Brussels
Stephanie Kromar (Regulatory Affairs Manager) stephanie.kromar (at) eortc.org, EORTC Headquarters, Brussels
Saskia Litiere (Statistician) saskia.litiere (at) eortc.org, EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) sandrine.marreaud (at) eortc.org, EORTC Headquarters, Brussels
Jean-Paul Nzanzu (Clinical Research Associate/Monitor) jean-paul.nzanzu (at) eortc.org, EORTC Headquarters, Brussels
Axelle Nzokirantevye (Data Manager) axelle.nzokirantevye (at) eortc.org, EORTC Headquarters, Brussels
Miguel Remis (Clinical Research Associate/Monitor) miguel.remis (at) eortc.org, EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) sandrine.rivrain (at) eortc.org, EORTC Headquarters, Brussels
Lucia Senna (Clinical Operations Assistant) lucia.senna (at) eortc.org, EORTC Headquarters, Brussels
Ionela Stanciu (Junior Clinical Operations Manager) ionela.stanciu (at) eortc.org, 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 Centre NHS Foundation Trust (Bebington, Wirral, United Kingdom)
Gustave Roussy (Villejuif, France)
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)
Centers to be activated The Christie NHS Foundation Trust (Manchester, United Kingdom)
Protocol summary http://clinicaltrials.gov/ct/show/NCT02216578
NCT number NCT02216578
EudraCT 2014-000501-13