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A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Prostatic Neoplasms

Thank you

Trial Information

A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

Inclusion Criteria:

- Histologically diagnosed prostate cancer

- Evidence of metastatic disease

- Evidence of progression, by rising PSA, nodal/visceral disease, bone scan, or local

- Serum testosterone ≤ 50 ng/dL

- Must be able to take oral medications

- Performance status 0, 1 or 2

Exclusion Criteria:

- Symptomatic brain or leptomeningeal metastases

- Clinically significant cardiovascular disease

- Pleural or pericardial effusion

- Currently active second malignancy

- Uncontrolled intercurrent illness

- Prior cytotoxic chemotherapy, with the exception of estramustine

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Assessed at each study visit (every 3 weeks while on treatment and every 12 weeks during follow-up) to death

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:

October 2008

Completion Date:

February 2013

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms



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