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Sponsored by: |
Hamamatsu University |
Information provided by: | Hamamatsu University |
ClinicalTrials.gov Identifier: | NCT00197431 |
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.
Condition | Intervention | Phase |
Gastric Cancer Esophageal Cancer Pancreatic Cancer Colon Cancer |
Drug: S-1 |
Phase II |
MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders Pancreatic Cancer Stomach Cancer |
ChemIDplus related topics: | S 1 (Combination) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
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 |
Ages Eligible for Study: | 20 Years to 85 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Naohito Shirai, MD., PhD | 81-534-2788 | naohito@hama-med.ac.jp |
Japan, Shizuoka | |||||
Hamamatsu University School of Medicine | Recruiting | ||||
Hamamatsu, Shizuoka, Japan, 431-3192 | |||||
Contact: Naohito Shirai, MD., PhD 81-534-2870 naohito@hama-med.ac.jp | |||||
Principal Investigator: Takahisa Furuta, MD., PhD |
Hamamatsu University |
Study Chair: | Naohito Shirai, MD., PhD | Department Laboratory Medicine, Hamamatsu University School of Medicine |
Study ID Numbers: | S-12005 |
First Received: | September 12, 2005 |
Last Updated: | March 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00197431 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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