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

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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00197431
Enrollment
Unknown
Registered
2005-09-20
Start date
2004-01-31
Completion date
Unknown
Last updated
2006-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer

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-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.

Interventions

DRUGS-1

Sponsors

Hamamatsu University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years

Inclusion criteria

* Patients with digestive organ cancer

Exclusion criteria

* Patients without digestive organ cancer

Design outcomes

Primary

MeasureTime frame
Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes

Secondary

MeasureTime frame
Side effect and motility of patients treated with S-1

Countries

Japan

Contacts

Primary ContactNaohito Shirai, MD., PhD
naohito@hama-med.ac.jp81-534-2788

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026