A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors
I. To determine the objective tumor response rate of BAY 43-9006 (sorafenib tosylate) in
patients with advanced neuroendocrine tumors.
I. Adverse event rate(s). II. Progression free survival and time to progression. III.
Improvement in circulating hormone levels. IV. Overall survival.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type
(carcinoid vs islet cell/other well-differentiated tumor).
Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 2 years from study entry.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed response rate (CR or PR) estimated by the number of successes divided by the total number of evaluable patients
Kaplan-Meier methodology will be used to estimate the final success proportion (i.e., confirmed response rate with a 95% confidence interval).
Up to 2 years
United States: Food and Drug Administration
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