Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00174564
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2005-09-09
Brief Title:
EXIBIT Oxaliplatin in Biliary Tract Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicentre Phase II Trial of Gemcitabine and Oxaliplatin GEMOX in Patients With Biliary Tract Cancer
Status:
COMPLETED
Status Verified Date:
2012-02
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:
The primary objective is to evaluate the efficacy of the GEMOX treatment as 1st line therapy in patients with advanced biliary tract cancer based on response rate measured by the RECIST unidimensional criteria
Secondary objectives are Progression free survival overall survival and safety
Secondary objectives are Progression free survival overall survival and safety
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