This phase II trial is studying how well saracatinib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES: I. To determine whether the Src kinase inhibitor, AZD0530 (saracatinib), has single agent clinical activity in patients with advanced melanoma. II. To determine whether this drug will increase progression-free survival of these patients from 3 months to 4.5 months. SECONDARY OBJECTIVES: I. To determine whether this drug may inhibit the activation of peripheral blood T cells analyzed ex vivo. OUTLINE: Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Objective Response Rate
Response will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum LD; Objective response = CR + PR. CT scans will be performed at baseline and every 4-8 weeks while on study.
Time frame: Up to 25 weeks
Progression-free Survival
Progression will be evaluated in this study using the RECIST criteria (the appearance of new lesions and/or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study). Progression-free survival time was calculated as the time from treatment start to date of progression or death, whichever comes first.
Time frame: Up to 2 years
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