A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer
I. Determine the feasibility and tolerability of sorafenib and interferon alfa in patients
with locally advanced or metastatic renal cell carcinoma.
II. Determine the response rate (complete response and partial response) in patients treated
with this regimen.
I. Determine the progression-free survival and response duration of patients treated with
II. Correlate changes in laboratory parameters with response in patients treated with this
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a
week for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or
Patients with stable or responding disease are followed every 3 months for 2 years, every 6
months for 2 years, and then annually for 1 year or until disease progression.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 10 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (CR+PR) using RECIST criteria
CR+PR rate will be calculated with exact 90% confidence intervals.
Up to 5 years
United States: Food and Drug Administration
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