Saracatinib in Treating Patients With Prostate Cancer
|Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer||Drug: saracatinib Other: hydrocortisone/placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Discontinuation Phase 2 Study of AZD0530 as a Metastasis Inhibitor in Castrate Resistant Prostate Cancer|
- Duration of Stable Disease. (Time to Disease Progression by CT and/or Bone Scan or Clinical Progression.) [ Time Frame: Up to 6 months. ]Time to progression will be assessed using the Kaplan-Meier method and compared between groups via Wilcoxon rank-sum test.
- Toxicity and Incidence of Adverse Events [ Time Frame: Up to 6 months. ]Percentage of patients with grade 4 toxicity.
- Toxicity and Incidence of Adverse Events. [ Time Frame: Up to 6 months. ]Percentage of patients who discontinued therapy due to toxicity.
- Correlation of Molecular Profile With Clinical Outcomes [ Time Frame: Up to 2 years ]Study terminated after randomization of only 8 subjects. Correlative data not analyzed.
|Study Start Date:||December 2010|
|Study Completion Date:||November 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm I (saracatinib)
Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other Name: AZD0530
Placebo Comparator: Arm II (placebo)
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267266
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|NorthShore University HealthSystem-Evanston Hospital|
|Evanston, Illinois, United States, 60201|
|Ingalls Memorial Hospital|
|Harvey, Illinois, United States, 60426|
|Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Peoria, Illinois, United States, 61615|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 60702|
|Southern Illinois University|
|Springfield, Illinois, United States, 62702|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology Inc-Parkview|
|Fort Wayne, Indiana, United States, 46845|
|United States, Maryland|
|University of Maryland Greenebaum Cancer Center|
|Baltimore, Maryland, United States, 21201-1595|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Saint John's Mercy Medical Center|
|Saint Louis, Missouri, United States, 63141|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|University of Wisconsin Women's Health Center|
|Madison, Wisconsin, United States, 53715|
|Froedtert and the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Walter Stadler||University of Chicago|