Last updated on September 2016

Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors


Brief description of study

The purpose of this study is to evaluate the effect of entinostat on heart rate and other electrocardiogram parameters. This study will also evaluate the safety and tolerability of entinostat, as well as pharmacokinetic and pharmacodynamic parameters.

Detailed Study Description

This is a single center, randomized, placebo-controlled, single dosing schedule, double-blinded study to evaluate the effect of entinostat as compared to placebo on the electrical activity of the heart in patients with advanced solid tumors. Thirty patients will be randomized in a 1:1 ratio to receive either entinostat or placebo. Study treatment will be blinded to patients and the Investigator. ECG analysts will be blinded to the patient, visit, and treatment allocation. Patients will be on study up to 30 days following study drug administration. Total study duration is expected to be 9 months. After completing this study and at the discretion of the Investigator, patients may elect to enroll into a separate continuation study (SNDX-275-0141).

Clinical Study Identifier: NCT02897778

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Anthony W. Tolcher, MD

The START Center for Cancer Care
San Antonio, TX United States
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