Spots Global Cancer Trial Database for Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone

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Trial Identification

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

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

Study ID: NCT01867866

Conditions

Advanced Solid Tumors

Interventions

TAS-102

Trifluridine

Study Description

Brief 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.