Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090025
Status:
TERMINATED
Last Update Posted:
2009-01-14
First Post:
2004-08-19
Brief Title:
XL119 Versus 5-Fluorouracil 5-FU Plus Leucovorin LV in Subjects With Advanced Biliary Tumors
Sponsor:
Helsinn Healthcare SA
Organization:
Helsinn Healthcare SA
Study Overview
Official Title:
A Phase 3 Multicenter Open Label Randomized Study of XL119 Versus 5-Fluorouracil 5-FU Plus Leucovorin LV in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery
Status:
TERMINATED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility reasons after Independent Data Monitoring Committee interim analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil 5FU and leucovorin LV in prolonging the survival of subjects with advanced biliary tumors
Detailed Description:
None
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