CompletedPhase 1NCT02897778

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

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.

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

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorSyndax Pharmaceuticals
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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

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

04
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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