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

NCT02897778 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-28

No results posted yet for this 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.

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

Interventions

DRUG

Entinostat

Single, supratherapeutic dose of entinostat given orally.

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Michael Meyers, MD, PhD · Syndax Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-24
Primary Completion
2017-03-13
Completion
2017-03-13

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02897778 on ClinicalTrials.gov