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Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Phase II Study of Dasatinib (BMS-354825) for Androgen-deprived Progressive Prostate Cancer

Inclusion Criteria:

- males, 18 or older

- proven advanced prostate cancer

- documented metastatic disease

- rising PSA levels

- castrate levels of testosterone

Exclusion Criteria:

- symptomatic CNS (brain or spinal cord) metastasis

- medical condition which may increase the risk of toxicity

- any prior or ongoing anti-cancer medical therapy or immunotherapy for prostate cancer
other than primary androgen deprivation agents

- unable to take oral medication

Type of Study:


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:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

October 2010

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



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