Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005938
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2000-07-05
Brief Title:
DX-8951f in Treating Patients With Biliary 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 Biliary Tree Cancer Cholangiocarcinoma and Gallbladder Cancer
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 biliary cancer
PURPOSE Phase II trial to study the effectiveness of DX-8951f in treating patients who have biliary cancer
Detailed Description:
OBJECTIVES I Determine the antitumor activity of DX-8951f in terms of antitumor response response duration and survival in patients with biliary tree cancer II Evaluate the quantitative and qualitative toxicities of this treatment regimen in this patient population III Evaluate the pharmacokinetics of DX-8951 in plasma
OUTLINE Patients receive DX-8951f IV over 30 minutes daily for 5 days Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for survival
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 12 months
OUTLINE Patients receive DX-8951f IV over 30 minutes daily for 5 days Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for survival
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| UTHSC-9905011256 | None | None | None |
| DAIICHI-8951A-PRT020 | None | None | None |
| MDA-ID-99379 | None | None | None |
| MSKCC-99110 | None | None | None |
| SACI-IDD-99-31 | None | None | None |
| UCHSC-00892 | None | None | None |