drugset / Trial / NCT00197431

Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer

NCT00197431

Phase 2 Unknown Hamamatsu University
Non-randomizedSingle-groupOpen-labelTreatment

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-2,4-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.

Timeline

Start
2004-01
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject S-1 Small molecule Oral
Background 5-chloro-2,4-dihydropyridine Unknown Oral
Background oteracil Small molecule Oral