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

Completed · Phase 1 · Has a placebo group

Conditions studied: Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Bronchial Neoplasms, Lung Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Digestive System Neoplasms, Endocrine Gland Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Breast Neoplasms, Breast Diseases, Renal Neoplasm, Solid Tumors

In brief

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.

Key facts

Study ID

NCT02897778

Run by

Syndax Pharmaceuticals

People needed

30

Starts

2016-08-24

Expected to finish

2017-03-13

Last updated by the study team

2022-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The START Center for Cancer Care — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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