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Brief Title: Zalutumumab in Non-curable Patients With SCCHN
Official Title: An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.
Study ID: NCT00542308
Brief Summary: Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Loma Linda University Cancer Institute, Loma Linda, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
Mountain States Tumor Institute, Boise, Idaho, United States
University Of Chicago Medical Center, Chicago, Illinois, United States
Ft. Wayne Medical Oncology/Hematology, Inc, Fort Wayne, Indiana, United States
Henry Ford Health Systems, Detroit, Michigan, United States
Oregon Health and Science University, Portland, Oregon, United States
Baylor University Medical Center, Dallas, Texas, United States
Medizinische Universität Graz, Graz, , Austria
Universitätsklinik für Innere Medizin III, Salzburg, , Austria
AKH Wien, Wien, , Austria
Instituto Clinico Oncologico del Sur ICOS, Temuco, , Chile
Hospital Carlos Van Buren de Valparaiso, Valparaiso, , Chile
Instituto Oncologico, Viña del Mar, , Chile
Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A, Bogota, , Colombia
Hospital Pablo Tobon Uribe, Medellin, , Colombia
Oncomedica S.A., Montería, , Colombia
Oncólogos del Occidente S.A., Pereira, , Colombia
Facultni Nemocnice Hradec Kralove, Hradec Králové, , Czechia
Nemocnice Jihlava, Jihlava, , Czechia
Veseobecna Fakultni Nemocnice, Prague, , Czechia
Facultni Nemocnice Na Bulovce, Prague, , Czechia
Universitätsklinikum Essen, Essen, , Germany
Klinikum der Johann Wolfgang Goethe Universität, Frankfurt am Main, , Germany
Uniklinik Freiburg, Freiburg, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Medizinische Universitätsklinik Lübeck, Lübeck, , Germany
Südharz-Krankenhaus Nordhausen gGmbH, Nordhausen, , Germany
Soroka Medical Center, Beer Sheva, , Israel
Rambam Medial Center, Haifa, , Israel
Shaare-Zedek Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Sheba Medical Center, Ramat-Gan, , Israel
Sourasky Medical Center, Tel-Aviv, , Israel
Istituto Nazionale Tumori, Milan, , Italy
Istituto Europea di Oncologia, Milan, , Italy
Azienda Ospedaliera Valtellina e Valchiavenna, Sondrio, , Italy
Hospital Goyeneche, Arequipa, , Peru
Hospital Nacional Carlos Alberto Seguin Escobedo, Arequipa, , Peru
Hospital Nacional Almanzor Aguinaga Asenjo, Lambayeque, , Peru
Hospital Central FAP, Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen, Lima, , Peru
IPO Coimbra, Coimbra, , Portugal
IPO Lisboa, Lisboa, , Portugal
IPO Porto, Porto, , Portugal
Narodny onkologicky ustav, Bratislava, , Slovakia
FN Trnava, Trnava, , Slovakia
Name: Steen Lisby, MD
Affiliation: Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
Role: STUDY_DIRECTOR