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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono

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