Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004866
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2000-03-07
Brief Title:
DX-8951f in Treating Women Who Have Advanced or Recurrent Cancer of the Cervix
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced or Recurrent Squamous Cell Cancer of the Cervix
Status:
COMPLETED
Status Verified Date:
2012-05
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 DX-8951f in treating women who have advanced or recurrent cancer of the cervix
PURPOSE Phase II trial to study the effectiveness of DX-8951f in treating women who have advanced or recurrent cancer of the cervix
Detailed Description:
OBJECTIVES
Determine the antitumor activity of DX-8951f in women with advanced or recurrent squamous cell carcinoma of the cervix
Evaluate the quantitative and qualitative toxic effects of this regimen in these patients
Evaluate the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive DX-8951f IV over 30 minutes daily for 5 days Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 37 patients will be accrued for this study
Determine the antitumor activity of DX-8951f in women with advanced or recurrent squamous cell carcinoma of the cervix
Evaluate the quantitative and qualitative toxic effects of this regimen in these patients
Evaluate the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive DX-8951f IV over 30 minutes daily for 5 days Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 37 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAIICHI-8951A-PRT015 | None | None | None |
| MDA-DM-99247 | None | None | None |