Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone
NCT01867866 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2024-09-05
Summary
The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Taiho Oncology, Inc.
lead INDUSTRY
Principal Investigators
-
Drew Rasco, MD · South Texas Accelerated Research Therapeutics, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2013-10-31
- Completion
- 2016-06-30
Countries
- United States
Study Locations
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