A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Metastatic Hormone Refractory Prostate Cancer
Male
Metastatic Hormone Refractory Prostate Cancer
Trial Information
A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer
Inclusion Criteria:
- Metastatic hormone refractory prostate cancer progressing after docetaxel based
therapy
- Adequate bone marrow, liver and kidney function
Exclusion Criteria:
- More than one prior chemotherapy line
- Uncontrolled hypertension
- Brain or leptomeningeal disease
- Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure,
cerebrovascular accident in the previous 6 months
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group
Outcome Time Frame:
within the first three months of treatment
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
AURA-6202-007
NCT ID:
NCT00766324
Start Date:
September 2007
Completion Date:
April 2011
Related Keywords:
- Metastatic Hormone Refractory Prostate Cancer
- Prostatic Neoplasms
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