180
Participants
Start Date
April 30, 2011
Primary Completion Date
April 30, 2013
Study Completion Date
July 31, 2014
EMD 525797
Subjects will be administered with EMD 525797 at a dose of 1500 milligram (mg) (diluted with 0.9 percent \[%\] sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.
EMD 525797
Subjects will be administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.
Placebo
Subjects will be administered with placebo (as 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.
Standard of Care (SoC)
All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).
Research Site, Pleasant Hill
Research Site, Chicago
Research Site, New Orleans
Research Site, Ann Arbor
Research Site, Detroit
Research Site, New Brunswick
Research Site, Cleveland
Research Site, Dallas
Research Site, Houston
Research Site, Tyler
Research Site, Roanoke
Research Site, Spokane
Research Site, Bendigo
Research Site, Coffs Harbour
Research Site, Darlinghurst
Research Site, Frankston
Research Site, Gosford
Research Site, Kurralta Park
Research Site, Northmead
Research Site, Port Macquarie
Research Site, Randwick
Research Site, Turnhout
ZNA Middelheim Oncologie, Antwerp
Brandord Urology Research, Brantford
Exdeo Clinical Research Inc., Abbotsford
Can-Med Clinical Research Inc., Province of British Columbia
Sunnybrook Health Sciences Centre, Toronto
Research Site, Victoria
Research Site, Windsor
Research Site, Angers
Center Alexis Vaurrin, Bourgogne
Research Site, Caen
Hôpitaux Civils de Colmar-CH Louis Pasteur, Colmar
Research Site, Paris
Research Site, Reims
Institute Gustave Roussy, Villejuif
Research Site, Aachen
Universitätsmedizin Charité, Campus Benjamin Franklin, Urologische Klinik and Poliklinik, Berlin
Research Site, Darmstadt
Universitätsklinikum Carl Gustav Carus an der Techischen Universität Dresden, Klinik und Poliklinik für Urologie, Dresden
Research Site, Esslingen am Neckar
Research Site, Freiburg im Breisgau
Research Site, Hanover
Research Site, Nürtingen
Studienpraxis Urologie, Reutlingen
Universitätsklinikum Tübinger, Klinik und Poliklinik für Urologie, Tübingen
Research Site, Blaricum
Research Site, Groningen
Research Site, Haarlem
Research Site, Gdansk
Research Site, Lodz
Research Site, Lublin
Altay Regional Oncology Dispensary, Barnaul
Research Site, Barnaul
State Institution of Healthcare Ivanovo Regional Oncology Dispensary, Ivanovo
Budzhet Clinical Oncology Center, Izhevsk
Research Site, Kazan'
Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary, Krasnoyarsk
Research Site, Omsk
City Hospital # 2, Saint Petersburg
Research Site, Stavropol
Research Site, Yekaterinburg
Research Site, Prešov
Research Site, Gauteng
Research Site, Kwa-Zulu Natal
Research Site, Pretoria Gauteng
Research Site, Western Cape
Research Site, Barcelona
Research Site, Madrid
Research Site, Pamplona
Research Site, Sabadell, Barcelone
Lead Sponsor
EMD Serono
INDUSTRY