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Brief Title: EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer
Official Title: An Open-label, Randomized, Controlled, Multicenter, Phase I/II Trial Investigating 2 EMD 525797 Doses in Combination With Cetuximab and Irinotecan Versus Cetuximab and Irinotecan Alone, as Second-line Treatment for Subjects With K-ras Wild Type Metastatic Colorectal Cancer (mCRC)
Study ID: NCT01008475
Brief Summary: The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Brussels, , Belgium
Research Site, Edegem, , Belgium
Research Site, Gent, , Belgium
Research Site, Leuven, , Belgium
Research Site, Sofia, , Bulgaria
Research Site, Strovolos, Nicosia, Cyprus
Research Site, Brno, , Czech Republic
Research Site, Horovice, , Czech Republic
Research Site, Kutna Hora, , Czech Republic
Research Site, Olomouc, , Czech Republic
Research Site, Pardubice, , Czech Republic
Research Site, Prague, , Czech Republic
Research Site, Dresden, , Germany
Research Site, Essen, , Germany
Research Site, Freiburg, , Germany
Research Site, Hamburg, , Germany
Research site, Hannover, , Germany
Research Site, Heilbronn, , Germany
Research Site, Landshut, , Germany
Research Site, Leipzig, , Germany
Research Site, Munich, , Germany
Research Site, Recklinghausen, , Germany
Research Site, Ulm, , Germany
Research Site, Thessaloniki, Cyprus, Greece
Research Site, Mournies Chania, , Greece
Research Site, Budapest, , Hungary
Research Site, Gyor, , Hungary
Research Site, Kecskemet, , Hungary
Research Site, Miskolc, , Hungary
Research Site, Nyiregyhaza, , Hungary
Research Site, Szolnok, , Hungary
Research Site, Haifa, , Israel
Research Site, Jerusalem, , Israel
Research Site, Ramat Gan, , Israel
Research Site, Rechovot, , Israel
Research Site, Tel-Aviv, , Israel
Research Site, Elblag, , Poland
Research Site, Gdańsk, , Poland
Research Site, Gliwice, , Poland
Research Site, Rybnik, , Poland
Research Site, Warszawa, , Poland
Research Site, Łódź, , Poland
Research, Arkhangelsk, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Novosibirsk, , Russian Federation
Research Site, Omsk, , Russian Federation
Research Site, St. Petersburg, , Russian Federation
Research Site, Tomsk, , Russian Federation
Research Site, Barcelona, , Spain
Research Site, Elche, , Spain
Research Site, Madrid, , Spain
Research Site, Mallorca, , Spain
Research Site, Santander, , Spain
Research Site, Santiago de Compostela, , Spain
Research Site, Terrassa, , Spain
Research Site, Valencia, , Spain
Research Site, Aberdeen, , United Kingdom
Research Site, Glasgow, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Nottingham, , United Kingdom
Research Site, Sutton, , United Kingdom
Name: Medical Responsible
Affiliation: Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
Name: Prof. Josep Tabernero
Affiliation: HU Vall d' Hebron, Servei d'oncologia. E difici General
Role: PRINCIPAL_INVESTIGATOR