Trials / Unknown
UnknownNCT00197431
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Hamamatsu University · Academic / Other
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | S-1 |
Timeline
- Start date
- 2004-01-01
- First posted
- 2005-09-20
- Last updated
- 2006-03-22
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00197431. Inclusion in this directory is not an endorsement.