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NCT00197431 Clinical Trial

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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00197431
Other study ID # S-12005
Secondary ID
Status Recruiting
Phase Phase 2
First received September 12, 2005
Last updated March 21, 2006
Start date January 2004

Study information
Verified date December 2003
Source Hamamatsu University
Contact Naohito Shirai, MD., PhD
Phone 81-534-2788
Email naohito@hama-med.ac.jp
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients with digestive organ cancer

Exclusion Criteria:

- Patients without digestive organ cancer

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• S-1

Locations
Country Name City State
Japan Hamamatsu University School of Medicine Hamamatsu Shizuoka

Sponsors (1)
Lead Sponsor Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes
Secondary Side effect and motility of patients treated with S-1
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