Phase I/II Study of Dasatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Metastatic Prostate Cancer
Male
Metastatic Prostate Cancer
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 Center | Houston, Texas 77030-4009 |
