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Brief Title: EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Study ID: NCT01360840
Brief Summary: The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Research Site, Pleasant Hill, California, United States
Research Site, Chicago, Illinois, United States
Research Site, New Orleans, Louisiana, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Detroit, Michigan, United States
Research Site, New Brunswick, New Jersey, United States
Research Site, Cleveland, Ohio, United States
Research Site, Dallas, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Tyler, Texas, United States
Research Site, Roanoke, Virginia, United States
Research Site, Spokane, Washington, United States
Research Site, Bendigo, , Australia
Research Site, Coffs Harbour, , Australia
Research Site, Darlinghurst, , Australia
Research Site, Frankston, , Australia
Research Site, Gosford, , Australia
Research Site, Kurralta Park, , Australia
Research Site, Northmead, , Australia
Research Site, Port Macquarie, , Australia
Research Site, Randwick, , Australia
Research Site, Turnhout, , Australia
ZNA Middelheim Oncologie, Antwerp, , Belgium
Brandord Urology Research, Brantford, Ontario, Canada
Exdeo Clinical Research Inc., Abbotsford, , Canada
Can-Med Clinical Research Inc., Province of British Columbia, , Canada
Sunnybrook Health Sciences Centre, Toronto, , Canada
Research Site, Victoria, , Canada
Research Site, Windsor, , Canada
Research Site, Angers, , France
Center Alexis Vaurrin, Bourgogne, , France
Research Site, Caen Cedex 05, , France
Hôpitaux Civils de Colmar-CH Louis Pasteur, Colmar, , France
Research Site, Paris, , France
Research Site, Reims, , France
Institute Gustave Roussy, Villejuif, , France
Research Site, Aachen, , Germany
Universitätsmedizin Charité, Campus Benjamin Franklin, Urologische Klinik and Poliklinik, Berlin, , Germany
Research Site, Darmstadt, , Germany
Universitätsklinikum Carl Gustav Carus an der Techischen Universität Dresden, Klinik und Poliklinik für Urologie, Dresden, , Germany
Research Site, Esslingen, , Germany
Research Site, Freiburg, , Germany
Research Site, Hannover, , Germany
Research Site, Nürtingen, , Germany
Studienpraxis Urologie, Reutlingen, , Germany
Universitätsklinikum Tübinger, Klinik und Poliklinik für Urologie, Tübingen, , Germany
Research Site, Blaricum, , Netherlands
Research Site, Groningen, , Netherlands
Research Site, Haarlem, , Netherlands
Research Site, Gdańsk, , Poland
Research Site, Lublin, , Poland
Research Site, Łódź, , Poland
Altay Regional Oncology Dispensary, Barnaul, , Russian Federation
Research Site, Barnaul, , Russian Federation
Research Site, Ekaterinburg, , Russian Federation
State Institution of Healthcare Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
Budzhet Clinical Oncology Center, Izhevsk, , Russian Federation
Research Site, Kazan, , Russian Federation
Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary, Krasnoyarsk, , Russian Federation
Research Site, Omsk, , Russian Federation
City Hospital # 2, Petersburg, , Russian Federation
Research Site, Stavropol, , Russian Federation
Research Site, Presov, , Slovakia
Research Site, Gauteng, , South Africa
Research Site, Kwa-Zulu Natal, , South Africa
Research Site, Pretoria Gauteng, , South Africa
Research Site, Western Cape, , South Africa
Research Site, Barcelone, , Spain
Research Site, Madrid, , Spain
Research Site, Pamplona, , Spain
Research Site, Sabadell, Barcelone, , Spain
Name: Medical Responsible
Affiliation: EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR