NCT01867866

Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TAS-102	35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
DRUG	Trifluridine	35 mg/m2, orally, single dose

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-10-01
• Completion: 2016-06-01
• First posted: 2013-06-04
• Last updated: 2024-09-05

Locations

1 site across 1 country: United States