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

Advanced Solid Tumors Clinical Trial

Official title:
A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone

Clinical Trial Summary

The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01867866
Study type Interventional
Source Taiho Oncology, Inc.
Contact
Status Completed
Phase Phase 1
Start date May 2013
Completion date June 2016
View Details
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