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Brief Title: Efficacy and Safety Study of Multiple Doses of IMAB362 in Patients With Advanced Gastroesophageal Cancer
Official Title: International, Multicenter, Open-label, Phase II Study to Investigate the Efficacy and Safety of Multiple Doses of IMAB362 in Patients With Advanced Adenocarcinoma of the Stomach or the Lower Esophagus
Study ID: NCT01197885
Brief Summary: IMAB362 is a monoclonal antibody specific for gastric or lower esophageal adenocarcinoma. Preclinically IMAB362 was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase II study is to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Oncology Dispensary "Dr. Marko Markov", Varna, , Bulgaria
MHAT "St.Marina", Varna, , Bulgaria
Complex Oncology Center, Veliko Turnovo, , Bulgaria
CharitÊ - Universitätsmedizin Berlin, Berlin, , Germany
Medizinische Univeritätsklinik Ruhr-Universität Bochum, Bochum, , Germany
Klinikum Braunschweig, Braunschweig, , Germany
Universitätsklinikum Essen, Innere Klinik (Tumorforschung), Essen, , Germany
Krankenhaus Nordwest, Klinik fßr Onkologie und Hämatologie, Frankfurt, , Germany
Universitätsklinikum Halle, Halle, , Germany
Universitäres Cancer Center Universitätsklinikum Eppendorf, Hamburg, , Germany
Onkologische Schwerpunktpraxis Eppendorf, Hamburg, , Germany
Universitätsklinikum Heidelberg, NCT, Heidelberg, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
Universitätsmedizin der Johannes-Gutenberg Universität, Mainz, , Germany
Klinikum rechts der Isar, Muenchen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Piejuras Hospital, Liepaja, , Latvia
Paula Stradina Clinical University Hospital, Riga, , Latvia
Riga East Clinical Research, Riga, , Latvia
Vilnius University, Vilnius, , Lithuania
Kantonsspital St. Gallen, St.Gallen, , Switzerland
Name: Martin Schuler, Prof. Dr. med.
Affiliation: Innere Klinik Universitätsklinikum Essen
Role: PRINCIPAL_INVESTIGATOR