Phase II Study of Dasatinib (BMS-354825) for Androgen-Deprived Progressive Prostate Cancer - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00385580

Purpose

The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Prostate Cancer	Drug: dasatinib	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Dasatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Dasatinib (BMS-354825) for Androgen-Deprived Progressive Prostate Cancer

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

response rate of adding dasatinib to ongoing androgen deprivation [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
response rate includes PSA changes and radiographic bone scan results [ Time Frame: every four weeks for PSA and every 12 weeks for bone scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

assess the safety and tolerability [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
identify well tolerated dose in this patient population [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
assess changes in markers of bone loss [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: dasatinib Tablets, Oral, 70 mg, twice daily, treatment may continue until disease progression

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385580

Locations

United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
The Bunting Blaustein Cancer Research Building
Baltimore, Maryland, United States, 21231
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, Wisconsin
University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr
Madison, Wisconsin, United States, 53792
France
Local Institution
Montpellier, France, 34298
Local Institution
Villejuif Cedex, France, 94800
Italy
Local Institution
Rome, Italy, 00152

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-085
Study First Received:	October 4, 2006
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00385580
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Dasatinib

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009