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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Premiere Oncology of Arizona
Scottsdale, Arizona, United States
Yale Cancer Center
New Haven, Connecticut, United States
University of Kentucky/Division of Hematology/Oncology and Blood Marrow Transplantation
Lexington, Kentucky, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Institute for Drug Development
San Antonio, Texas, United States
Start Date
February 1, 2006
Primary Completion Date
November 1, 2008
Completion Date
March 1, 2009
Last Updated
September 3, 2024
24
ESTIMATED participants
S-1/Cisplatin
DRUG
Lead Sponsor
Taiho Oncology, Inc.
NCT02586194
NCT04823702
NCT04136444
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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