A Phase II Study of BAY 43-9006 (NSC #724772) in Patients With Malignant Mesothelioma
I. To determine the response rate (partial response (PR) and complete response (CR)) in
patients with malignant mesothelioma treated with BAY 43-9006.
I. To determine 3-month failure free survival in patients with malignant mesothelioma
treated with BAY 43-9006.
II. To describe the median and overall survival of malignant mesothelioma patients treated
with BAY 43-9006.
III. To describe the toxicity profile of BAY 43-9006 in patients with malignant
IV. To determine whether mesotheliomas contain mutations in exons 11 and 15 of the B-raf
gene and correlate these findings with anti-tumor activity of BAY 43-9006.
V. To determine whether the amount of expression of phospho-ERK1/2, as determined by
immunohistochemistry from pre-treatment tumor specimens, correlates with anti-tumor activity
of BAY 43-9006 in patients with mesothelioma.
VI. To determine whether baseline levels and changes following BAY 43-9006 treatment in
angiogenic cytokines (VEGF and PDGF) correlate with anti-tumor activity of BAY 43-9006.
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.
After completion of study treatment, patients are followed at least every 2 months for 1
year, every 4 months for 1 year, and then every 6 months for 1 year.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (including complete and partial response)
The frequency of best response to the new treatment will be tabulated and the exact 95% binomial confidence intervals will be computed.
Up to 3 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Cancer and Leukemia Group B||Chicago, Illinois 60606|