Spots Global Cancer Trial Database for Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors
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Trial Identification
Brief Title: Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors
Official Title: A Phase 1 Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors
Study ID: NCT02897778
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the effect of entinostat on heart rate and other electrocardiogram (ECG) parameters. This study will also evaluate the safety and tolerability of entinostat, as well as pharmacokinetic and pharmacodynamic parameters.
Detailed 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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The START Center for Cancer Care, San Antonio, Texas, United States
Contact Details
Name: Michael Meyers, MD, PhD
Affiliation: Syndax Pharmaceuticals
Role: STUDY_DIRECTOR
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