NCT01867879

Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors

A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered TAS-102 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the cardiac safety of TAS-102 in patients with advanced solid tumors.

Detailed description

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).

Conditions

• Advanced Solid Tumors (Excluding Breast Cancer)

Interventions

Type	Name	Description
DRUG	TAS-102	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	Placebo	Placebo tablets, orally, single dose.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-08-01
• Completion: 2015-04-01
• First posted: 2013-06-04
• Last updated: 2024-09-05

Locations

1 site across 1 country: United States