A Randomized Discontinuation Phase 2 Study of AZD0530 as a Metastasis Inhibitor in Castrate Resistant Prostate Cancer
I. Determine if AZD0530 (saracatinib) increases time to radiographic progression in men with
CRPC compared to placebo.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to disease progression by CT and/or bone scan
Time to progression will be assessed using the Kaplan-Meier method and compared between groups via the logrank test.
Up to 2 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Loyola University Medical Center||Maywood, Illinois 60153|
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Decatur Memorial Hospital||Decatur, Illinois 62526|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|M D Anderson Cancer Center||Houston, Texas 77030|
|Froedtert and the Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|
|Illinois CancerCare-Peoria||Peoria, Illinois 61615|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Fort Wayne, Indiana 46845|
|Saint John's Mercy Medical Center||Saint Louis, Missouri 63141|
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|
|University of Michigan University Hospital||Ann Arbor, Michigan 48109|
|Southern Illinois University||Springfield, Illinois 62702|