Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
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
Stage IIA Melanoma
Stage IIB Melanoma
Stage IIC Melanoma
Stage IV Melanoma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of AZD0530 in Metastatic Melanoma|
- Objective Response Rate [ Time Frame: Up to 25 weeks ] [ Designated as safety issue: No ]
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.
- Progression-free Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2006|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.
Other Name: AZD0530
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669019
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Thomas Gajewski||University of Chicago Comprehensive Cancer Center|