Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398424
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2006-11-08
Brief Title:
Evaluating Patients With Impaired Hepatic Function
Sponsor:
Taiho Oncology Inc
Organization:
Taiho Oncology Inc
Study Overview
Official Title:
A Phase I Open-Label Study Evaluating The Pharmacokinetics of Components of S-1 Patients With Impaired Hepatic Function
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Six patients will be enrolled inot each cohort and receive S-1
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None