A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered TAS-102 in Patients With Advanced Solid Tumors
This is a Phase 1, nonrandomized study to evaluate the cardiac safety of TAS-102 in patients
with advanced solid tumors. The study is conducted in 2 phases: the cardiac safety
evaluation phase to investigate cardiac repolarization and the cardiac safety profile (Cycle
1) and the extension phase to assess the safety profile and antitumor activity (subsequent
cycles).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
QTc interval
Predose (Day -2) to post-dose changes and absolute values in QTc interval after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1)
Days -2, -1, 1, and 12 of Cycle 1
Yes
Johanna Bendell, MD
Principal Investigator
Sarah Cannon Research Institute
United States: Food and Drug Administration
TPU-TAS-102-103
NCT01867879
June 2013
July 2014
Name | Location |
---|---|
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |