Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer

Hamamatsu University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer; Gastric Cancer; Colon Cancer; Pancreatic Cancer

Treatments: Drug: S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT00197431

S-12005

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with digestive organ cancer

Exclusion criteria

• Patients without digestive organ cancer

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)