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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
Sponsor:
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00197431
First received: September 12, 2005
Last updated: March 21, 2006
Last verified: December 2003
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Hamamatsu University:

Primary Outcome Measures:
  • Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes

Secondary Outcome Measures:
  • Side effect and motility of patients treated with S-1
Study Start Date: January 2004
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on March 03, 2015