Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003951
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
1999-11-01
Brief Title:
DX-8951f in Treating Patients With Metastatic Cancer of the Pancreas
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 Carcinoma of the Pancreas
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 patients who have metastatic cancer of the pancreas that has not been previously treated or that has not responded to previous chemotherapy
PURPOSE Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic cancer of the pancreas that has not been previously treated or that has not responded to previous chemotherapy
Detailed Description:
OBJECTIVES I Determine the objective response rate in patients with metastatic carcinoma of the exocrine pancreas treated with DX-8951f II Determine the time to tumor progression in patients receiving this drug III Determine the survival at 6 and 12 months of patients receiving this drug IV Evaluate the quantitative and qualitative toxicities of this regimen in this patient population V Evaluate the pharmacokinetics of this drug in this patient population
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 |
|---|---|---|---|
| DAIICHI-8951A-PRT009 | None | None | None |
| JHOC-99062405 | None | None | None |
| MSKCC-99014 | None | None | None |