A Phase II Study of BAY 43-9006 for Imatinib- and Sunitinib-Resistant Malignant Gastrointestinal Stromal Tumor
I. To determine the objective response rate of patients with imatinib and
sunitinib-resistant malignant gastrointestinal stromal tumor who are treated with BAY
I. To determine the toxicity experienced by patients with imatinib and sunitinib -resistant
malignant gastrointestinal stromal tumor who are treated with BAY 43-9006.
II. To determine progression-free survival and overall survival in patients with imatinib
and sunitinib -resistant malignant gastrointestinal stromal tumor who are treated with BAY
I. To examine if mutational status of KIT and PDGFA in patients with imatinib- and sunitinib
resistant malignant gastrointestinal stromal tumor correlate with response to BAY 43-9006.
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
treatment with imatinib mesylate and sunitinib malate (imatinib mesylate- and sunitinib
malate-responsive disease vs primary imatinib mesylate- and sunitinib malate-refractory
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 periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (partial response [PR] or complete response [CR])
Objective response will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria from the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is documented. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A 5% response rate precludes further study whereas a 20% response rate would indicate that further investigation of the treatment is warranted.
Computed Tomography (CT) scans for disease reassessment will be obtained pre-therapy and every 8 weeks. In addition to a baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of objective response.
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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