NCT02301104

A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TAS-102

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-11-25
• Last updated: 2024-09-05

Locations

8 sites across 1 country: United States