Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT01867866
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2013-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone
Sponsor:
Taiho Oncology, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone
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:
The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
Detailed Description:
This is a Phase 1, open-label, randomized, parallel, 2-group study evaluating the PK of FTD as a TAS-102 component compared with FTD alone in patients with advanced solid tumors (excluding breast cancer). Patients will be randomized to receive a single dose of TAS-102 or FTD during the PK contribution phase and will receive continuing cycles of TAS-102 during the extension phase.
Study Oversight
Has Oversight DMC:
False
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?: