Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436241
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2007-02-16
Brief Title:
A Study of Xeloda Capecitabine as First-Line Chemotherapy in Patients With Advanced or Metastatic Gastric Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Open Label Study of the Effect of First-line Therapy With Xeloda in Combination With Oxaliplatin on Overall Response Rate in Patients With Locally Advanced andor Metastatic Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2016-11
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 single arm study will assess the efficacy and safety of Xeloda in combination with oxaliplatin as first-line chemotherapy in patients with advanced andor metastatic gastric cancer who have had no prior chemotherapy for advanced or metastatic disease Eligible patients will receive Xeloda 1000mgm2 po twice daily D1-D10 every 2 weeks 10 days treatment followed by 4 days rest period plus oxaliplatin 85 mgm2day iv D1 every 2 weeks The anticipated time on study treatment is until disease progression and the target sample size is 100 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