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).

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT01360840

Recruitment Status:

Completed

Sponsor:

EMD Serono

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There is 1 Location for this study

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Research Site
Pleasant Hill California, , United States
Research Site
Chicago Illinois, , United States
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New Orleans Louisiana, , United States
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Ann Arbor Michigan, , United States
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Detroit Michigan, , United States
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New Brunswick New Jersey, , United States
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Cleveland Ohio, , United States
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Dallas Texas, , United States
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Houston Texas, , United States
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Tyler Texas, , United States
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Roanoke Virginia, , United States
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Spokane Washington, , United States
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Bendigo , , Australia
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Coffs Harbour , , Australia
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Darlinghurst , , Australia
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Frankston , , Australia
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Gosford , , Australia
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Kurralta Park , , Australia
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Northmead , , Australia
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Port Macquarie , , Australia
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Randwick , , Australia
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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
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Victoria , , Canada
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Windsor , , Canada
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Angers , , France
Center Alexis Vaurrin
Bourgogne , , France
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Caen Cedex 05 , , France
Hôpitaux Civils de Colmar-CH Louis Pasteur
Colmar , , France
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Paris , , France
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Reims , , France
Institute Gustave Roussy
Villejuif , , France
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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
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Groningen , , Netherlands
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Haarlem , , Netherlands
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Gdańsk , , Poland
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Lublin , , Poland
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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
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Stavropol , , Russian Federation
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Presov , , Slovakia
Research Site
Gauteng , , South Africa
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Kwa-Zulu Natal , , South Africa
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Pretoria Gauteng , , South Africa
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Western Cape , , South Africa
Research Site
Barcelone , , Spain
Research Site
Madrid , , Spain
Research Site
Pamplona , , Spain
Research Site
Sabadell, Barcelone , , Spain

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT01360840

Recruitment Status:

Completed

Sponsor:


EMD Serono

How clear is this clinincal trial information?

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