Prostate Cancer Clinical Trial
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
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).
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason score)
Bisphosphonate treatment
Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (less than or equal to) <= 50 nanogram per deciliter [ng/dL]) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists)
Other protocol defined inclusion criteria could apply
Exclusion Criteria:
Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy for mCRPC
Chronic and ongoing treatment with opioids
Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening
Visceral metastasis, brain metastasis
Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any kinds of major elective surgery within 30 days prior to trial treatment
Other protocol defined exclusion criteria could apply
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There is 1 Location for this study
Pleasant Hill California, , United States
Chicago Illinois, , United States
New Orleans Louisiana, , United States
Ann Arbor Michigan, , United States
Detroit Michigan, , United States
New Brunswick New Jersey, , United States
Cleveland Ohio, , United States
Dallas Texas, , United States
Houston Texas, , United States
Tyler Texas, , United States
Roanoke Virginia, , United States
Spokane Washington, , United States
Bendigo , , Australia
Coffs Harbour , , Australia
Darlinghurst , , Australia
Frankston , , Australia
Gosford , , Australia
Kurralta Park , , Australia
Northmead , , Australia
Port Macquarie , , Australia
Randwick , , Australia
Turnhout , , Australia
Antwerp , , Belgium
Brantford Ontario, , Canada
Abbotsford , , Canada
Province of British Columbia , , Canada
Toronto , , Canada
Victoria , , Canada
Windsor , , Canada
Angers , , France
Bourgogne , , France
Caen Cedex 05 , , France
Colmar , , France
Paris , , France
Reims , , France
Villejuif , , France
Aachen , , Germany
Berlin , , Germany
Darmstadt , , Germany
Dresden , , Germany
Esslingen , , Germany
Freiburg , , Germany
Hannover , , Germany
Nürtingen , , Germany
Reutlingen , , Germany
Tübingen , , Germany
Blaricum , , Netherlands
Groningen , , Netherlands
Haarlem , , Netherlands
Gdańsk , , Poland
Lublin , , Poland
Åódź , , Poland
Barnaul , , Russian Federation
Barnaul , , Russian Federation
Ekaterinburg , , Russian Federation
Ivanovo , , Russian Federation
Izhevsk , , Russian Federation
Kazan , , Russian Federation
Krasnoyarsk , , Russian Federation
Omsk , , Russian Federation
Petersburg , , Russian Federation
Stavropol , , Russian Federation
Presov , , Slovakia
Gauteng , , South Africa
Kwa-Zulu Natal , , South Africa
Pretoria Gauteng , , South Africa
Western Cape , , South Africa
Barcelone , , Spain
Madrid , , Spain
Pamplona , , Spain
Sabadell, Barcelone , , Spain
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