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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: dasatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00385580

CA180-085

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: dasatinib

Drug: dasatinib

2

Experimental group

Treatment:

Drug: dasatinib

Drug: dasatinib