NCT00513071

AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description

PRIMARY OBJECTIVES: I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC). II. Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530. III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population. OUTLINE: This is a multicenter study. Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for the first 2 years and then yearly thereafter.

Conditions

• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer

Interventions

Type	Name	Description
DRUG	saracatinib	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-08-08
• Last updated: 2018-04-19
• Results posted: 2014-10-03

Locations

1 site across 1 country: United States