NCT00659360

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Adult Fibrosarcoma
• Adult Leiomyosarcoma
• Adult Liposarcoma
• Adult Malignant Fibrous Histiocytoma
• Adult Rhabdomyosarcoma
• Dermatofibrosarcoma Protuberans
• 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
• Uterine Carcinosarcoma
• Uterine Leiomyosarcoma

Interventions

Type	Name	Description
DRUG	saracatinib	Given orally

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-01-01
• Completion: 2012-11-01
• First posted: 2008-04-16
• Last updated: 2018-06-29
• Results posted: 2015-07-30

Locations

4 sites across 2 countries: United States, Canada