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Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI

NCT01874522 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-09-05

No results posted yet for this study

Summary

The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI.

Conditions

  • Advanced Solid Tumors (Excluding Breast Cancer)

Interventions

DRUG

TAS-102 tablets

Crossover bioavailability part: 60 mg/dose, orally, up to 2 single doses separated by 1-week washout. Extension part: 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

TAS-102 oral solution

60 mg/dose, orally, up to 2 single doses separated by 1-week washout

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Von Hoff, MD · Scottsdale Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-08-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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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 NCT01874522 on ClinicalTrials.gov