A Phase 2 Study of AZD0530 in Metastatic Melanoma
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.
I. To determine whether this drug may inhibit the activation of peripheral blood T cells
analyzed ex vivo.
Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease
progression or unacceptable toxicity.
After completion of study therapy, patients are followed for up to 8 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response will be evaluated in this study using the new international criteria proposed by 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. All of the patients who met the eligibility criteria (with the possible exception of those who received no study medication) should be included in the main analysis of the response rate.
At baseline and every 4-8 weeks for up to 8 weeks
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|