Impaired Hepatic Function Clinical Trial
Official title:
A Phase I, Open-Label Study Evaluating The Pharmacokinetics of Components of S-1 Patients With Impaired Hepatic Function
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their
metabolites in patients with advanced solid tumors and varying degrees of hepatic function
defined by the NCI classification for hepatic impairment. Patients will be stratified into 4
Cohorts- Normal, Mild, Moderate or Severe.
Six patients will be enrolled inot each cohort and receive S-1.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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