Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054015
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2003-02-05
Brief Title:
3-AP in Treating Patients With Advanced Prostate Cancer
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone 3-AP Triapine in Patients With Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2004-04
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 II trial to study the effectiveness of 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy
PURPOSE Phase II trial to study the effectiveness of 3-AP in treating patients who have advanced prostate cancer that has been previously treated with hormone therapy
Detailed Description:
OBJECTIVES
Determine the response rate in patients with advanced hormone-refractory prostate cancer treated with 3-AP
Determine the toxic effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive 3-AP IV over 2 hours on days 1-4 Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 2-3 months for up to 1 year
PROJECTED ACCRUAL Approximately 13-27 patients will be accrued for this study
Determine the response rate in patients with advanced hormone-refractory prostate cancer treated with 3-AP
Determine the toxic effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive 3-AP IV over 2 hours on days 1-4 Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 2-3 months for up to 1 year
PROJECTED ACCRUAL Approximately 13-27 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 |
|---|---|---|---|
| MCC-IRB-100798 | None | None | None |
| VION-CLI-024 | None | None | None |
| MCC-13110 | None | None | None |