EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer Metastatic

In brief

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).

Key facts

Study ID

NCT01360840

Run by

EMD Serono

People needed

180

Starts

2011-04-01

Expected to finish

2014-07-01

Last updated by the study team

2015-12-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 British Columbia, Canada
• Research Site — Pleasant Hill, California, United States

Full record on ClinicalTrials.gov

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