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Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Phase 1 Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors

NCT02897778•Syndax Pharmaceuticals

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of a solid tumor malignancy that is not responsive to standard therapy(ies) or for which there is no approved therapy
•Patients must have acceptable laboratory requirements
•Left ventricular ejection fraction as measured by echocardiogram or multiple-gated acquisition scan that is above the institutional lower level of normal or greater than 50%
•Has experienced resolution of toxic effect(s) of the most recent prior chemotherapy and/or prior surgical and radiation treatment
•Must be able to understand and give written informed consent and comply with study procedures

Exclusion Criteria

•If the patient has brain metastasis, they must have stable neurologic status without the use of steroids or on a stable or decreasing dose of steroids
•Presence of clinically significant gastrointestinal abnormalities that may affect the absorption of study treatments
•A medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the Investigator
•Patient has a concomitant cardiovascular issue that precludes adequate study treatment compliance or increases patient risk
•Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
•Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study
•Prior anti-cancer monoclonal antibody within 4 weeks prior to baseline
•Currently enrolled in another investigational study
•Has disease that is suitable for approved therapy administered with curative intent

Locations (1)

The START Center for Cancer Care

San Antonio, Texas, United States

Key Dates

Start Date

August 24, 2016

Primary Completion Date

March 13, 2017

Completion Date

March 13, 2017

Last Updated

April 28, 2022

Enrollment

ACTUAL participants

Conditions

NeoplasmsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsDigestive System NeoplasmsEndocrine Gland NeoplasmsCarcinoma, Non-Small-Cell LungLung DiseasesBreast NeoplasmsBreast DiseasesRenal NeoplasmSolid Tumors

Interventions

Entinostat

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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