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

Status:	Completed
Conditions:	Prostate Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	April 2011
End Date:	July 2014

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)

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).

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

We found this trial at

sites

Clinical Trial Facility in Ann Arbor Michigan

Ann Arbor, Michigan 48109

1903

from 98109

Ann Arbor, MI