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

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of entinostat on heart rate and other electrocardiogram parameters. This study will also evaluate the safety and tolerability of entinostat, as well as pharmacokinetic and pharmacodynamic parameters.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Syndax Pharmaceuticals
• Treatments: Entinostat; Histone Deacetylase Inhibitors

Criteria

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