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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. The completion date has passed and the status has not been verified in more than two years.
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

September 12, 2005
March 21, 2006
January 2004
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Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes
Whether the differences in activities of CYP2A6 and DPD effect on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes.
Complete list of historical versions of study NCT00197431 on ClinicalTrials.gov Archive Site
Side effect and motility of patients treated with S-1
Side effect and motility of patients who treated with S-1.
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Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer
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
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.
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Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastric Cancer
  • Esophageal Cancer
  • Pancreatic Cancer
  • Colon Cancer
Drug: S-1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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Inclusion Criteria:

  • Patients with digestive organ cancer

Exclusion Criteria:

  • Patients without digestive organ cancer
Both
20 Years to 85 Years   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00197431
S-12005
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Hamamatsu University
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Study Chair: Naohito Shirai, MD., PhD Department Laboratory Medicine, Hamamatsu University School of Medicine
Hamamatsu University
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP