Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197431
Status:
UNKNOWN
Last Update Posted:
2006-03-22
First Post:
2005-09-12
Brief Title:
Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer
Sponsor:
Hamamatsu University
Organization:
Hamamatsu University
Study Overview
Official Title:
Pharmacokinetic and Pharmacodynamic Study of S-1 and Its Effects in Patients With the Digestive Organ Cancer With Reference to Genetic Polymorphism and Activity of CYP2A6 and DPD
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
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 a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil 5-FU 5-chloro-24-dihydropyridine CDHP which inhibits dihydropyrimidine dehydrogenase DPD activity and potassium oxonate Oxo which reduces gastrointestinal toxicity 5-FU is metabolized by CYP2A6 and DPD In this study the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1
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