Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-04-02 @ 10:04 AM
Study NCT ID:
NCT02261532
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2014-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase I Study of TAS-102 in Solid Tumors
Sponsor:
Taiho Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-10
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 primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.
Detailed Description:
This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (Day1 and Day 12) of therapy in all consenting patients.
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?: