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

NCT ID: NCT02897778

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-24
• Study Completion Date: 2017-03-13

Brief 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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Entinostat

Participants received a single oral supratherapeutic dose of 15 mg entinostat under fasted conditions.

Group Type: ACTIVE_COMPARATOR

Entinostat

Intervention Type: DRUG

Single, supratherapeutic dose of entinostat given orally.

Placebo

Participants received a single dose of placebo-matching entinostat under fasted conditions.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose of placebo-matching entinostat (containing inactive ingredients matching the appearance of the active product).

Interventions

Entinostat

Single, supratherapeutic dose of entinostat given orally.

Intervention Type: DRUG

Placebo

Single dose of placebo-matching entinostat (containing inactive ingredients matching the appearance of the active product).

Intervention Type: DRUG

Other Intervention Names

SNDX-275; MS-275

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syndax Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Meyers, MD, PhD

Role: STUDY_DIRECTOR

Syndax Pharmaceuticals

Locations

The START Center for Cancer Care

San Antonio, Texas, United States

Countries

United States

Other Identifiers

SNDX-275-0140

Identifier Type: -

Identifier Source: org_study_id