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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEntinostat and Placebo

The study team can explain what participation involves.

Who it may be forNeoplasms · Neoplasms, Glandular and Epithelial

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 28, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Syndax Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Syndax Pharmaceuticals
Interventions being studied: Drug: Entinostat; Drug: Placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

The START Center for Cancer CareSan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 28, 2022. Always confirm current availability with the study team.

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