Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072787
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2003-11-10
Brief Title:
Phase 12 Study of S-1 and Cisplatin in Advanced Gastric Cancer
Sponsor:
Taiho Oncology Inc
Organization:
Taiho Oncology Inc
Study Overview
Official Title:
A Phase III Open-Label Nonrandomized Dose-Finding Safety Tolerance Pharmacokinetic and Efficacy Study of Orally Administered S-1 in Combination With Cisplatin in Patients With Advanced Gastric Cancer
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:
The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and cisplatin that can be administered in gastric cancer patients
The purpose of the phase 2 portion of the study is to determine the antitumor activity of the S-1 and cisplatin regimen established from phase 1 in patients with advanced gastric cancer
The purpose of the phase 2 portion of the study is to determine the antitumor activity of the S-1 and cisplatin regimen established from phase 1 in patients with advanced gastric cancer
Detailed Description:
S-1 is an oral fluoropyrimidine which combines tegafur a 5-FU prodrug with two classes of modulators which
inhibit dihydropyrimidine dehydrogenase DPD and
block phosphorylation of 5-FU in gastrointestinal tissues
S-1 is designed to enhance the the clinical utility of an oral fluoropyrimidine while ameliorating the disadvantage of gastrointestinal toxicity
5-Fu and cisplatin have been used as a standard treatment in gastric cancer and preliminary data indicate that S-1 plus cisplatin may result in superior tolerability and efficacy in advanced gastric cancer
S-1 is currently approved in Japan for treatment of gastric cancer and head and neck cancer
inhibit dihydropyrimidine dehydrogenase DPD and
block phosphorylation of 5-FU in gastrointestinal tissues
S-1 is designed to enhance the the clinical utility of an oral fluoropyrimidine while ameliorating the disadvantage of gastrointestinal toxicity
5-Fu and cisplatin have been used as a standard treatment in gastric cancer and preliminary data indicate that S-1 plus cisplatin may result in superior tolerability and efficacy in advanced gastric cancer
S-1 is currently approved in Japan for treatment of gastric cancer and head and neck cancer
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