Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046943
Status:
COMPLETED
Last Update Posted:
2011-02-21
First Post:
2002-10-03
Brief Title:
Atrasentan in Treating Patients With Prostate Cancer
Sponsor:
Abbott
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2003-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1400 patients will be accrued for this study
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 1400 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G02-2110 | None | None | None |
| ABBOTT-M00-258 | None | None | None |
| UCLA-0202002 | None | None | None |