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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

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:

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

Name

Location

Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Seattle Cancer Care AllianceSeattle, Washington  98109
University of ChicagoChicago, Illinois  60637
The Bunting Blaustein Cancer Research BuildingBaltimore, Maryland  21231
Memorial Sloan-Kettering Cancer Center-Sidney Kimmel CenterNew York, New York  10021
University Of Wisconsin Paul P Carbone Comprehensive Ca CtrMadison, Wisconsin  53792