Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00400179
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2005-06-30
Brief Title:
A Safety and Efficacy Study in Patients With Gastric Cancer
Sponsor:
Taiho Oncology Inc
Organization:
Taiho Oncology Inc
Study Overview
Official Title:
An Open-Label Multicenter Randomized Phase 3 Study of S-1 in Combination With Cisplatin Against 5-Fu in Combination W Cisplatin in Patients W Advanced Gastric Cancer Previously Untreated W Chemotherapy for Advanced Disease
Status:
COMPLETED
Status Verified Date:
2024-08
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 is an open-label international two-arm parallel randomized Phase 3 study evaluating the efficacy and safety of S-1cisplatin versus 5-FUcisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease Patients will be randomly assigned 11 to S-1cisplatin experimental arm or 5-FUcisplatin control arm Patients will be stratified by number of metastatic sites one vs more than one locally advanced or metastatic disease prior adjuvant therapy yes or no measurable or non-measurable disease and center
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