Recurrent Prostate Cancer Clinical Trial
Official title:
A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)
This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES:
I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA)
response rate and progression-free survival (PFS) in comparison with historical controls for
patients with hormone-refractory prostate cancer (HRPC).
II. Evaluate the time to treatment failure and overall survival of patients with HRPC treated
with AZD0530.
III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population.
OUTLINE: This is a multicenter study.
Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for the first 2
years and then yearly thereafter.
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