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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
Name: Drew Rasco, MD
Affiliation: South Texas Accelerated Research Therapeutics, LLC
Role: PRINCIPAL_INVESTIGATOR