Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma
I. Determine objective response rate in patients with locally advanced, metastatic, or
locally recurrent differentiated thyroid cancer treated with sorafenib (BAY 43-9006).
I. Determine the toxicity of this drug in these patients. II. Correlate thyroglobulin levels
with tumor response in patients treated with this drug.
III. Correlate fludeoxyglucose F 18 positron emission tomography results with tumor response
in patients treated with this drug.
IV. Correlate tumor permeability and vascularity, as determined by dynamic contrast-enhanced
MRI, with tumor response in patients treated with this drug.
V. Determine the pharmacodynamics of this drug in these patients. VI. Correlate the presence
and type of B-raf, N-ras, or RET/PTC gene mutations with clinical response in patients
treated with this drug.
VII. Correlate the degree of Ras-MAPK signaling inhibition and vascular endothelial growth
factor expression with clinical response in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis
(papillary thyroid cancer that is chemo-naïve vs all others).
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of
disease progression or unacceptable toxicity. Patients achieving complete remission (CR)
receive 8 additional weeks of therapy beyond CR.
Patients are followed within 2-4 weeks after completion of study treatment.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
The 95% confidence intervals should be provided.
Up to 4 weeks
Ohio State University
United States: Food and Drug Administration
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