EORTC-90101

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Cross-tumoral Phase 2 clinical trial exploring crizotinib (PF-02341066) in patients with advanced tumors induced by causal alterations of ALK and/or MET ("CREATE")

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 27-Aug-2012 Date Step1 close: 04-Jul-2017 Date Step2 close: 04-Jul-2017
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	EORTC Groups: 582 - All Groups: 582
Treatment	Drug Crizotinib
Study Staff	Patrick Schoeffski (Study Coordinator) , U.Z. Leuven - Campus Gasthuisberg, Leuven Lieve Dirix (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Axelle Nzokirantevye (Data Manager) , EORTC Headquarters, Brussels Xiao Mang Zhou (Junior RAM) , EORTC Headquarters, Brussels
Type of cancer	Non Hodgkins Lymphoma Kidney Soft Tissue and Bone Sarcoma
Participating groups
Recruiting centers	Centre Georges-Francois-Leclerc (DIJON CEDEX, France) Centre Leon Berard (Lyon, France) Gustave Roussy (VILLEJUIF CEDEX, France) Gustave Roussy (VILLEJUIF CEDEX, France) Helios Klinikum Bad Saarow (Bad Saarow-Pieskow, Germany) Hopital de La Timone (APHM) (MARSEILLE CEDEX 5, France) IRCCS - Fondazione Istituto Nazionale dei Tumori (Milano, Italy) Institut Bergonie (Bordeaux, France) Institut Jules Bordet (Anderlecht, Belgium) Leeds Teaching Hospitals NHS Trust - St. James's University Hospital (Leeds, United Kingdom) Leiden University Medical Centre (Leiden, Netherlands) Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern (Muenchen, Germany) Maria Sklodowska-Curie National Research Institute of Oncology (Warsaw, Poland) Medizinische Hochschule Hannover (Hannover, Germany) Narodny Onkologicky Ustav - Bratislava (Bratislava, Slovakia) Nottingham University Hospitals NHS Trust - City Hospital (Nottingham, United Kingdom) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) The Christie NHS Foundation Trust (Manchester, United Kingdom) The Institute Of Oncology (Ljubljana, Slovenia) U.Z. Leuven - Campus Gasthuisberg (Leuven, Belgium) UniversitaetsMedizin Mannheim (Mannheim, Germany) Universitaetsklinikum - Essen (Essen, Germany) Universitaetsklinikum Carl Gustav Carus (TUD) (Dresden, Germany) University College Hospital (London, United Kingdom)
Protocol summary	http://clinicaltrials.gov/study/NCT01524926
NCT number	NCT01524926
EudraCT	2011-001988-52
Financial Support	Educational Grant