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Phase I/II Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Male
Metastatic Prostate Cancer

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Trial Information

Phase I/II Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer


Inclusion Criteria:



- Males, 18 and older

- Confirmed adenocarcinoma of the prostate

- Radiographic evidence of progressive metastatic disease with serum PSA ≥ 5

- Serum testosterone ≤ 50

Exclusion Criteria:

- Known brain metastases

- Currently active secondary malignancy

- No more than one prior chemotherapy for prostate cancer, as long as docetaxel
resistance or intolerance was not shown

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Continuous safety assessment

Outcome Time Frame:

throughout treatment

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-086

NCT ID:

NCT00439270

Start Date:

July 2007

Completion Date:

January 2013

Related Keywords:

  • Metastatic Prostate Cancer
  • Metastatic hormone refractory prostate cancer
  • Prostatic Neoplasms

Name

Location

The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009