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

NCT00197431 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2006-03-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

S-1

Sponsors & Collaborators

  • Hamamatsu University

    lead OTHER

Principal Investigators

  • Naohito Shirai, MD., PhD · Department Laboratory Medicine, Hamamatsu University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00197431 on ClinicalTrials.gov