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

NCT ID: NCT00197431

Last Updated: 2006-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Esophageal Cancer Pancreatic Cancer Colon Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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S-1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with digestive organ cancer

Exclusion Criteria

* Patients without digestive organ cancer
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamamatsu University

OTHER

Sponsor Role lead

Principal Investigators

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Naohito Shirai, MD., PhD

Role: STUDY_CHAIR

Department Laboratory Medicine, Hamamatsu University School of Medicine

Locations

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Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Naohito Shirai, MD., PhD

Role: CONTACT

[email protected]
81-534-2788

Facility Contacts

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Naohito Shirai, MD., PhD

Role: primary

[email protected]
81-534-2870

Other Identifiers

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S-12005

Identifier Type: -

Identifier Source: org_study_id