Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With a Response
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].
Within 2 weeks of first study drug administration, thereafter recorded every 4 weeks.
United States: Food and Drug Administration
|Cedars Sinai Medical Center||Los Angeles, California 90048-1804|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|
|University of Chicago||Chicago, Illinois 60637|
|The Bunting Blaustein Cancer Research Building||Baltimore, Maryland 21231|
|Memorial Sloan-Kettering Cancer Center-Sidney Kimmel Center||New York, New York 10021|
|University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr||Madison, Wisconsin 53792|