Spots Global Cancer Trial Database for Atrasentan in Treating Patients With Prostate Cancer
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Trial Identification
Brief Title: Atrasentan in Treating Patients With Prostate Cancer
Official Title: A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
Study ID: NCT00046943
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.
Detailed Description: OBJECTIVES: * 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.
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Contact Details
Name: Gary Gordon, MD, PhD
Affiliation: Abbott
Role:
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