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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
Open (Enrolling)
Male
Prostate Cancer Metastatic

Thank you

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 SiteAnaheim, California  
Research SiteArlington Heights, Illinois  
Research SiteBaton Rouge, Louisiana  
Research SiteBattle Kreek, Michigan  
Research SiteBelleville, New Jersey  
Research SiteAkron, Ohio  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington