Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398307
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2006-11-08
Brief Title:
Evaluating Patients With Varying Degrees of Renal 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 in Patients With Varying Degrees of Renal 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 renal function Patients will be stratified by baseline 24-hour creatinine clearanceCrCL into 4 cohorts using the normal clearance formula
Group A Control Group BMild renal dysfunction Group CModerate renal function and Group D Severe renal dysfunction Six patients will be enrolled into each cohort
Group A Control Group BMild renal dysfunction Group CModerate renal function and Group D Severe renal dysfunction Six patients will be enrolled into each cohort
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