Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004046
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2000-05-02
Brief Title:
Chemotherapy in Treating Women With Metastatic Breast Cancer
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 Metastatic Adenocarcinoma of the Breast
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 metastatic breast cancer that has not responded to previous therapy
PURPOSE Phase II trial to study the effectiveness of DX-8951f in treating women who have metastatic breast cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the antitumor activity of DX-8951f in women with metastatic adenocarcinoma of the breast who have failed prior therapy with an anthracycline and a taxane II Evaluate the quantitative and qualitative toxicities of this drug in these patients III Evaluate the pharmacokinetics of this drug in these patients
OUTLINE Patients receive DX-8951f IV over 30 minutes daily for 5 days Courses repeat every 21 days Treatment continues in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study
OUTLINE Patients receive DX-8951f IV over 30 minutes daily for 5 days Courses repeat every 21 days Treatment continues in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 12-37 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 |
|---|---|---|---|
| MDA-ID-98308 | None | None | None |
| DAIICHI-8951A-PRT011 | None | None | None |