NCT02031055

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

A Phase 1, Open-label Study to Evaluate the Mass Balance of Orally Administered FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1, open-label study evaluating 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. The study will be conducted in 2 parts: mass balance part and TAS-102 extension part. After completion of the mass balance part, patients will receive continued treatment with TAS-102 during the study extension part.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-11-01
• Completion: 2015-06-17
• First posted: 2014-01-09
• Last updated: 2024-09-05

Locations

1 site across 1 country: United States