A Phase II Clinical and Correlative Study of BAY 43-9006 (Sorafenib) IND 69,896 in Sarcoma
I. To determine if the combined VEGF-R2/PDGFR beta inhibitor BAY 43-9006/ sorafenib can
decrease interstitial fluid pressure (IFP) in soft tissue sarcomas.
II. To investigate the effects of BAY 43-9006/sorafenib on tumor blood flow, circulating
endothelial cells, vascular density and pericyte coverage.
III. To characterize the pharmacokinetics of BAY 43-9006/sorafenib in sarcoma patients.
I. To describe any preliminary evidence of anti-tumor activity. II. Assess whether there are
any significant relationships between systemic drug exposure and drug-related toxicity or
OUTLINE: This is a multicenter study. Patients are assigned to one of two groups (group 1
closed to accrual as of 5/30/07).
GROUP I (SARCOMAS OF THE EXTREMITY) (CLOSED TO ACCRUAL AS OF 5/30/07): Patients receive oral
sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on
approximately day 15. Once patients recover from surgery (and radiotherapy if indicated),
patients who demonstrate a clinically and pathologically significant response (≥ 25%
reduction in tumor size or ≥ 25% necrosis in the surgical specimen) may continue sorafenib
as above for a maximum of 6 months in the absence of disease progression or unacceptable
toxicity and at the discretion of the principal investigator. Biopsy tissue and blood
samples are examined for biomarkers and interstitial fluid pressure (IFP) is measured at
baseline and immediately before surgery.
GROUP II (METASTATIC OR INOPERABLE SARCOMAS): Patients receive oral sorafenib twice daily on
days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable
disease may continue sorafenib in the absence of disease progression or unacceptable
toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at
baseline and on days 28 and 56.
In both groups, blood samples are drawn periodically for pharmacological studies.
After completion of study therapy, patients are followed monthly until all study-related
toxicities are resolved and then at the discretion of the investigator.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in FDG uptake (SUVmax)
Paired comparison made using a Wilcoxon signed rank test with one-sided type I error of 5%.
Baseline to up to 1 month post-treatment
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|