Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With a Response

Outcome Description:

Response = confirmed prostate specific antigen (PSA) response (decrease in PSA =>50% from baseline), confirmed improved bone scan (disappearance of => 1 lesion, no new lesions, new pain not developing), confirmed complete response (CR: disappearance of all lesions) or confirmed partial response (PR: =>30% in sum of longest diameter [LD] of all lesions compared to baseline sum LD), stable disease (SD: neither sufficient increase for progressive disease [PD: =>20% increase in sum of LD of all target lesions] nor sufficient shrinkage for PR), based on Response Criteria in Solid Tumors [RECIST].

Outcome Time Frame:

Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-085

NCT ID:

NCT00385580

Start Date:

January 2007

Completion Date:

October 2010

Related Keywords:

• Prostate Cancer
• Prostatic Neoplasms