EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
NCT ID: NCT01360840
Last Updated: 2015-12-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2011-04-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo + Standard of care (SoC)
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).
EMD 525797 750 mg + SoC
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.
Standard of Care (SoC)
All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).
EMD 525797 1500 mg + SoC
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.
Standard of Care (SoC)
All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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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, , 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 am Neckar, , Germany
Research Site
Freiburg im Breisgau, , Germany
Research Site
Hanover, , 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
Gdansk, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Altay Regional Oncology Dispensary
Barnaul, , Russia
Research Site
Barnaul, , Russia
State Institution of Healthcare Ivanovo Regional Oncology Dispensary
Ivanovo, , Russia
Budzhet Clinical Oncology Center
Izhevsk, , Russia
Research Site
Kazan', , Russia
Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary
Krasnoyarsk, , Russia
Research Site
Omsk, , Russia
City Hospital # 2
Saint Petersburg, , Russia
Research Site
Stavropol, , Russia
Research Site
Yekaterinburg, , Russia
Research Site
Prešov, , 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
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Pamplona, , Spain
Research Site
Sabadell, Barcelone, , Spain
Countries
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Other Identifiers
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EMR 62242-006
Identifier Type: -
Identifier Source: org_study_id