Trials / Completed
CompletedNCT00046943
Atrasentan in Treating Patients With Prostate Cancer
A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Abbott · Industry
- Sex
- Male
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | atrasentan hydrochloride |
Timeline
- Start date
- 2002-09-01
- Primary completion
- 2007-06-01
- First posted
- 2003-01-27
- Last updated
- 2011-02-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00046943. Inclusion in this directory is not an endorsement.