Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by Hamamatsu University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hamamatsu University
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00197431
First received: September 12, 2005
Last updated: March 21, 2006
Last verified: December 2003
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Purpose
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 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Help Me Understand Genetics
MedlinePlus related topics:
Cancer
Esophageal Cancer
Esophagus Disorders
Pancreatic Cancer
Stomach Cancer
U.S. FDA Resources
Further study details as provided by Hamamatsu University:
Eligibility
Ages Eligible for Study: | 20 Years to 85 Years |
Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Patients with digestive organ cancer
Exclusion Criteria:
- Patients without digestive organ cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197431
Contacts
Contact: Naohito Shirai, MD., PhD | 81-534-2788 | naohito@hama-med.ac.jp |
Locations
Japan | |
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 |
Sponsors and Collaborators
Hamamatsu University
Investigators
Study Chair: | Naohito Shirai, MD., PhD | Department Laboratory Medicine, Hamamatsu University School of Medicine |
More Information
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00197431 History of Changes |
Other Study ID Numbers: | S-12005 |
Study First Received: | September 12, 2005 |
Last Updated: | March 21, 2006 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
Colonic Neoplasms Esophageal Diseases Esophageal Neoplasms Stomach Neoplasms Pancreatic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Head and Neck Neoplasms Stomach Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on October 16, 2012