Phase II Trial of Imatinib(Gleevec®) in Selected Patients With Metastatic Melanoma
Only patients who meet the inclusion and exclusion criteria will be enrolled. The estimated
recruitment duration is 1 year. Imatinib will be given in the dose of 400 mg orally each day
unless disease progression or intolerance. The follow-up is 12 months.
Forty-eight subjects will be recruited for this study. This sample size is justified by the
number of patients required to establish an improvement in PFS with statistical significance
compared to historical control.
The standardized RECIST (Response Evaluation Criteria in Solid Tumors) method of
unidimensional tumor assessment will be employed to evaluate tumor lesion size per 2 months
in the determination of response rate and progression free survival. Repeated radiographic
assessment at 4 week intervals is consistent with general oncological practice associated
with computerized tomography (CT) or magnetic resonance imaging (MRI) scan testing. All
efficacy endpoints will be evaluated by the investigator.
Safety will be characterized in terms of the incidence, timing, severity, and relatedness of
adverse events and laboratory abnormalities. Severity will be graded according to the NCI
CTCAE Version 3.0.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
China: Food and Drug Administration