This phase II trial is studying how well AZD0530 works in treating patients with recurrent locally advanced, or metastatic soft tissue sarcoma. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
OBJECTIVES: I. To assess the efficacy of AZD0530, in terms of disease control rate (i.e., response rate and stable disease rate), in patients with recurrent locally advanced or metastatic soft tissue sarcoma. II. To assess the toxicity, time to progression, and response duration of AZD0530 in these patients. OUTLINE: This is a multicenter study. Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Given orally
Fox Chase Cancer Center
Rockledge, Pennsylvania, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.
Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Time frame: Up to 5 years
Objective Response Rate
Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions
Time frame: Up to 5 years
Overall Survival
Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.
Time frame: Up to 5 years
Stable Disease Rate
Achieved stable disease as their best response
Time frame: Up to 5 years
Duration of Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Tumor Response "of more than 4 months" was counted toward the Disease Control Rate.
Time frame: Up to 5 years
Time to Disease Progression
The Kaplan-Meier method will be used to estimate time to progression estimates. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to 5 years
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