Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454636
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2007-03-30
Brief Title:
A Study of Xeloda Capecitabine in Combination With Chemotherapy in Patients With Advanced andor Metastatic Gastric Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Open Label Phase II Study of Capecitabine Xeloda as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced andor Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen
Status:
COMPLETED
Status Verified Date:
2016-08
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:
This study will assess the safety and efficacy of Xeloda given in combination with standard chemotherapy regimens for the first-line treatment of advanced andor metastatic gastric cancer All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens the dose of Xeloda will be from 625mgm2 - 1000mgm2 bid orally depending on the chemotherapy regimen used The anticipated time on study treatment is until disease progression and the target sample size is 100-500 individuals
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