Clinical Trial Details

EORTC-90101-NOCI

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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
Edith Bastiaens (Data Manager) , EORTC Headquarters, Brussels
Kin Jip Cheung (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Giovanna Farro (Clinical Scientist) , 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
Tiana Raveloarivahy (Data Manager) , EORTC Headquarters, Brussels
Sofia Salgado (Regulatory Affairs Administrator) , 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 EORTC Network of Core Institutions
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)
National Cancer Institute - 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 (Dresden, Germany)
University College Hospital (London, United Kingdom)
Protocol summary http://clinicaltrials.gov/ct/show/NCT01524926
NCT number NCT01524926
EudraCT 2011-001988-52
Financial Support Educational Grant