NCT02301117

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (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 renal 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 renal 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: 2019-06-19
• Completion: 2019-06-19
• First posted: 2014-11-25
• Last updated: 2024-09-05

Locations

14 sites across 3 countries: United States, Czechia, Serbia