Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00400023
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2006-11-14
Brief Title:
A Phase 1 Open-Label Randomized Cross-Over Pharmacokinetic Study Evaluating the Effect of S-1 on Advanced Solid Tumors
Sponsor:
Taiho Oncology Inc
Organization:
Taiho Oncology Inc
Study Overview
Official Title:
A Phase 1 Open-Label Randomized Cross-Over Pharmacokinetic Study Evaluating the Effect of the Dihydropyrimidine Dehydrogenase Dpd Inhibitory Action of 5-Chloro-24-Dihydroxypyridine Cdhp as an S-1 Component
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 1 open-label randomized 2-sequence cross-over pharmacokinetic PK study evaluating the effect of the DPD inhibitory action of CDHP as an S-1 component compared with FT alone on the PK of 5-FU in patients with advanced solid tumors The study will be conducted in 2 parts Cross-Over Pharmacokinetic Phase and S-1 Extension Phase
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