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

NCT ID: NCT00385580

Last Updated: 2013-04-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

dasatinib

Intervention Type DRUG

Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression

2

Group Type EXPERIMENTAL

dasatinib

Intervention Type DRUG

Tablets, Oral, 100 mg, once daily (QD) treatment may continue until disease progression

Interventions

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dasatinib

Tablets, Oral, 100 mg or 70 mg, twice daily, treatment may continue until disease progression

Intervention Type DRUG

dasatinib

Tablets, Oral, 100 mg, once daily (QD) treatment may continue until disease progression

Intervention Type DRUG

Other Intervention Names

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Sprycel BMS-354825

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

University Of Chicago

Chicago, Illinois, United States

Site Status

The Bunting Blaustein Cancer Research Building

Baltimore, Maryland, United States

Site Status

Memorial Sloan-Kettering Cancer Center-Sidney Kimmel Center

New York, New York, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr

Madison, Wisconsin, United States

Site Status

Local Institution

Montpellier, , France

Site Status

Local Institution

Paris, , France

Site Status

Local Institution

Villejuif, , France

Site Status

Local Institution

Rome, , Italy

Site Status

Countries

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United States France Italy

References

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Yu EY, Wilding G, Posadas E, Gross M, Culine S, Massard C, Morris MJ, Hudes G, Calabro F, Cheng S, Trudel GC, Paliwal P, Sternberg CN. Phase II study of dasatinib in patients with metastatic castration-resistant prostate cancer. Clin Cancer Res. 2009 Dec 1;15(23):7421-8. doi: 10.1158/1078-0432.CCR-09-1691. Epub 2009 Nov 17.

Reference Type BACKGROUND
PMID: 19920114 (View on PubMed)

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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CA180-085

Identifier Type: -

Identifier Source: org_study_id