A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
- Determine the safety of atrasentan in patients with hormone-refractory prostate cancer.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral atrasentan once daily for 3 years in the absence of disease
progression or unacceptable toxicity.
Patients are followed at 1 month and then every 3 months for 2 years.
PROJECTED ACCRUAL: Approximately 1,400 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Gary Gordon, MD, PhD
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|