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Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors

NCT02031055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-09-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of \[14C\]FTD or \[14C\]TPI.

Conditions

Interventions

DRUG

TAS-102 with a light tracer dose of [14C]FTD

A single dose of 60 mg TAS-102 with a light tracer dose (200 nCi, approximately 1.2 μg) of \[14C\]FTD administered as an oral solution on Day 1 (mass balance part)

DRUG

TAS-102 with a light tracer dose of [14C] TPI

A single dose of 60 mg TAS-102 with a light tracer dose (1000 nCi, approximately 5.6 μg) of \[14C\]TPI administered as an oral solution on Day 1 (mass balance part)

DRUG

TAS-102 tablets

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. Treatment starts during study extension part (day 9 of the study).

Sponsors & Collaborators

  • Taiho Oncology, Inc.

    lead INDUSTRY

Principal Investigators

  • Jan H Beumer, PharmD, PhD · University of Pittsburgh

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-11-30
Completion
2015-06-17

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02031055 on ClinicalTrials.gov