AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma
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.
Adult Malignant Fibrous Histiocytoma
Endometrial Stromal Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Uterine Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage III Uterine Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Stage IV Uterine Sarcoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma|
- 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. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]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
- Objective Response Rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
- Overall Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.
- Stable Disease Rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Achieved stable disease as their best response
- Duration of Response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
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 to Disease Progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
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.
|Study Start Date:||February 2008|
|Study Completion Date:||November 2012|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.
Other Name: AZD0530
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659360
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Rockledge, Pennsylvania, United States, 19046|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|Principal Investigator:||Margaret von Mehren||University Health Network-Princess Margaret Hospital|