NCT01267266

Saracatinib in Treating Patients With Prostate Cancer

A Randomized Discontinuation Phase 2 Study of AZD0530 as a Metastasis Inhibitor in Castrate Resistant Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This randomized phase II clinical trial is studying how well saracatinib works in treating patients with prostate cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. Determine if AZD0530 (saracatinib) increases time to radiographic progression in men with CRPC compared to placebo. SECONDARY OBJECTIVES: I. Describe the adverse events related to AZD0530 in this population. II. Explore the role of FYN and other SRC kinase expression as a predictor of response to AZD0530. OUTLINE: This is a multicenter study. LEAD-IN PHASE: Patients receive oral saracatinib once daily during for 8 weeks. Patients who achieve disease regression or a PSA decrease of \> 50% continue to receive open-label saracatinib. Patients who do not show radiographic evidence of new metastases on bone scan and CT, disease regression, or a \> 50% decrease in PSA continue on to the randomized phase. RANDOMIZED PHASE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I. Tissue samples may be collected for correlative studies. After completion of study treatment, patients are followed up for 12 months.

Conditions

• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	saracatinib	Given orally
OTHER	hydrocortisone/placebo	Given orally

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-09-01
• Completion: 2013-11-01
• First posted: 2010-12-28
• Last updated: 2015-04-01
• Results posted: 2015-04-01

Locations

15 sites across 1 country: United States