Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer
Recruitment status was Active, not recruiting
The purpose of this research study is to find out if a new anti-cancer drug, dasatinib (Sprycel®), previously approved for treatment of some forms of leukemia, will be safe and helpful in treating patients with hormone-refractory prostate cancer.
This is a research study because the study drug, dasatinib (Sprycel®), has not been evaluated for safety or effectiveness in patients with hormone-refractory prostate cancer. The drug is approved by the Food and Drug Administration for treatment of some forms of leukemia; thus, dasatinib (Sprycel®) is not an investigational drug. It has been given safely to hundreds of patients already. However its safety and usefulness in this study population (prostate cancer) is unknown.
Subjects who agree to participate will take 150mg (3 pills) of dasatinib (Sprycel®) daily by mouth for as long as the drug benefits them. During this time, the subject will periodically return to the office for blood/urine tests, X-rays, imaging scans, and/or to complete questionnaires.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||BMS CA180-097: A Phase II Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer, Previously Treated With Chemotherapy|
- Define the frequency of "positive effects" from dasatinib treatment of subjects with hormone-refractory prostate cancer, who have had prior chemotherapy. [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Michael B Lilly, MD, FACP||Chao Family Comprehensive Cancer Center|