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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Given orally
Given orally
University of Chicago
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.)
Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.
Time frame: Up to 6 months.
Toxicity and Incidence of Adverse Events
Percentage of patients with grade 4 toxicity.
Time frame: Up to 6 months.
Toxicity and Incidence of Adverse Events.
Percentage of patients who discontinued therapy due to toxicity.
Time frame: Up to 6 months.
Correlation of Molecular Profile With Clinical Outcomes
Study terminated after randomization of only 8 subjects. Correlative data not analyzed.
Time frame: Up to 2 years
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