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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867866 on ClinicalTrials.gov