Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer
I. Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer
treated with sorafenib.
II. Determine the clinical toxic effects of this drug in these patients.
I. Determine the 24-week progression-free survival rate in patients treated with this drug.
II. Determine the overall survival of patients treated with this drug. III. Determine the
time to disease progression in patients treated with this drug.
IV. Correlate predictive disease markers (K-ras and B-raf mutations and ERK/pERK, AKT/pAKT,
and VEGFR2/p-VEGFR2 expression) in these patients with the activity of this drug.
OUTLINE: This is a 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 every 6 months for up to 5 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed tumor response according to RECIST criteria
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
Up to 5 years
North Central Cancer Treatment Group
United States: Food and Drug Administration
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