Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2025-12-17 @ 5:31 PM
Study NCT ID:
NCT00072787
Status:
None
Last Update Posted:
2024-09-03 00:00:00
First Post:
2003-11-10 00:00:00
Brief Title:
Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer
Sponsor:
Taiho Oncology Inc
Organization:
Taiho Oncology, Inc.
Study Overview
Official Title:
A Phase I/II, 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:
None
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:
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.
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