8
Participants
Start Date
February 28, 2014
Primary Completion Date
November 30, 2014
Study Completion Date
June 17, 2015
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)
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)
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).
University of Pittsbutgh Cancer Institute, Pittsburgh
Taiho Oncology, Inc.
INDUSTRY