Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT02301104
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2014-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment
Sponsor:
Taiho Oncology, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAS-102 in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment.
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:
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of hepatic impairment.
Detailed Description:
This is a Phase 1, open-label study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors with varying degrees of hepatic impairment. The study is conducted in 2 parts: the Pharmacokinetic Part (Cycle 1) and the Extension Part (Cycles 2 and beyond). Patients may continue to receive treatment with TAS-102 during the study extension part only after completion of the Pharmacokinetic Part.
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?: