2004-01
N/A
N/A
N/A
NCT00197431
Hamamatsu University
Hamamatsu University
INTERVENTIONAL
Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2005-09-12 | N/A | 2006-03-21 |
2005-09-12 | N/A | 2006-03-22 |
2005-09-20 | N/A | 2003-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Side effect and motility of patients treated with S-1 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Naohito Shirai, MD., PhD Phone Number: 81-534-2788 Email: naohito@hama-med.ac.jp |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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