A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer
I. To determine the response rate, time to tumor progression, and overall survival in
patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy
regimen for metastatic disease.
II. To assess the toxicities of STI571 in these patients. III. To obtain preliminary data on
molecular correlates to determine clinical efficacy and toxicity.
OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk
[chemonaïve] vs poor risk [1 prior chemotherapy regimen]).
Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4
weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 1-1.5
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response as determined by the RECIST criteria
Will be calculated as the percent of evaluable patients whose best response is a CR or PR, and exact 95% confidence intervals will be calculated for this estimate.
Up to 6 years
Beckman Research Institute
United States: Food and Drug Administration
|City of Hope||Duarte, California 91010|