A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer Metastatic
Male
Prostate Cancer Metastatic
Trial Information
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)
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) for subjects without
surgical castration (luteinizing hormone-releasing hormone antagonists and agonists)
- Additional inclusion criteria also 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
- Additional exclusion criteria also apply
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Clinical anti-tumor activity assessed as progression free survival (PFS)
Outcome Time Frame:
up to 3 months after last subject randomized
Safety Issue:
No
Principal Investigator
Heinrich Lannert, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Merck KGaA
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
EMR 62242-006
NCT ID:
NCT01360840
Start Date:
April 2011
Completion Date:
October 2013
Related Keywords:
- Prostate Cancer Metastatic
- Asymptomatic
- mildly symptomatic
- metastatic castrate-resistant prostate cancer
- mCRPC
- Prostatic Neoplasms
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Arlington Heights, Illinois |
| Research Site | Baton Rouge, Louisiana |
| Research Site | Battle Kreek, Michigan |
| Research Site | Belleville, New Jersey |
| Research Site | Akron, Ohio |
| Research Site | Abilene, Texas |
| Research Site | Abington, Virginia |
| Research Site | Auburn, Washington |
