A Phase II Study Of BAY 43-9006 (NSC 724772; CTEP IND# 69,896) In Patients With Hormone Refractory Prostate Cancer
OBJECTIVES:
- Determine the efficacy of sorafenib, as measured by prostate-specific antigen response,
in patients with metastatic or recurrent hormone-refractory adenocarcinoma of the
prostate.
Secondary
- Determine the objective response rate and duration of response in patients treated with
this drug.
- Determine the tolerability and toxicity of this drug in these patients.
- Determine time to treatment failure and overall survival in patients treated with this
drug.
- Explore the relationship between measures of ras/raf pathway activation (pERK) and
response to treatment in these patients.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks after going off study treatment and then periodically for
survival. Patients with stable or responding disease, when they go off study treatment, are
followed every 3 months until relapse or progression.
PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study within 12-18
months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate-specific antigen response and/or progression
2 years
No
Kim N. Chi, MD
Study Chair
British Columbia Cancer Agency
Canada: Health Canada
I167
NCT00093457
July 2004
January 2011
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