Clinical Trial: AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: 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 ]

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


Original Primary Outcome: Disease control rate or objective tumor response plus prolonged stable disease rate (defined as partial or complete response by RECIST criteria, or stable disease > 4 months)

Current Secondary Outcome:

  • Objective Response Rate [ Time Frame: Up to 5 years ]
    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 ]
    Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.
  • Stable Disease Rate [ Time Frame: Up to 5 years ]
    Achieved stable disease as their best response
  • Duration of Response [ Time Frame: Up to 5 years ]

    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 ]

    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.



Original Secondary Outcome:

  • Objective Response Rate
  • Median survival time
  • Overall survival (i.e., median, 6-month, and 1-year)
  • Response and stable disease duration
  • Time to disease progression (i.e., median, 6-month, 1-year)
  • Stable Disease Rate
  • Toxicity


Information By: National Cancer Institute (NCI)

Dates:
Date Received: April 15, 2008
Date Started: February 2008
Date Completion:
Last Updated: July 2, 2015
Last Verified: June 2014