Trial of Dasatinib (Sprycel®) in Subjects With Hormone-refractory Prostate Cancer
Summary
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.
Timeline
- Start
- 2007-07
- Primary completion
- 2012-02
- Completion
- 2012-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dasatinib anhydrous | Small molecule | 70 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 100 mg | Oral |
| Subject | dasatinib anhydrous | Small molecule | 150 mg | Oral |