NCT02897778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

August 24, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2017

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

August 20, 2016

Last Update Submit

April 21, 2022

Conditions

NeoplasmsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsDigestive System NeoplasmsEndocrine Gland NeoplasmsCarcinoma, Non-Small-Cell LungLung DiseasesBreast NeoplasmsBreast DiseasesRenal NeoplasmSolid Tumors

Keywords

entinostatsolid tumorHistone Deacetylase Inhibitors

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline in Heart Rate (HR)

    Heart rate measured in beats per minute (bpm).

    Baseline (pre-dose) through 24 hours post-dose

  • Change from Baseline in Electrocardiogram Procedures

    Change from baseline in QT interval corrected for heart rate (Qtc), PR interval (PR) and QRS complex (QRS).

    Baseline (pre-dose) through 24 hours post-dose

  • Change from Baseline in T-Cell Morphology

    Baseline (pre-dose) through 24 hours post-dose

Secondary Outcomes (12)

  • Number of Participants with Treatment-emergent Adverse Events (TEAES) and Serious Adverse Events (SAEs)

    First dose through 30 days post-dose or through resolution of acute toxicities (Up to 31 days)

  • Number of Participants with Clinically Significant Abnormalities in Laboratory Values Reported as a TEAE

    Baseline (pre-dose) through 14 days post-dose or 30 day safety follow-up visit (if applicable)

  • Change from Baseline in Vital Signs

    Baseline (pre-dose) through 14 days post-dose or 30 day safety follow-up visit (if applicable)

  • Change from Baseline in ECG Values

    Baseline ()pre-dose through 14 days post-dose or 30 day safety follow-up visit (if applicable)

  • Change from Baseline in QTc

    Pre-dose through 24 hours post-dose

  • +7 more secondary outcomes

Other Outcomes (2)

  • Changes in Immune Regulatory Cells after a Single Dose of Entinostat, when given at a Supratherapeutic Dose, Relative to Placebo Control

    Pre-dose through 14 days post-dose

  • Variability and Changes in Protein Lysine Acetylation in Peripheral Blood Cells after a Single Dose of Entinostat, when given at a Supratherapeutic Dose and Examine the Underlying Biological Variation

    Pre-dose through 14 days post-dose

Study Arms (2)

Entinostat

ACTIVE COMPARATOR

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

Drug: Entinostat

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

EntinostatDRUG

Single, supratherapeutic dose of entinostat given orally.

Also known as: SNDX-275, MS-275
Entinostat
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The START Center for Cancer Care

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

NeoplasmsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsDigestive System NeoplasmsEndocrine Gland NeoplasmsCarcinoma, Non-Small-Cell LungLung DiseasesBreast NeoplasmsBreast DiseasesKidney Neoplasms

Interventions

entinostat

Condition Hierarchy (Ancestors)

Neoplasms by SiteBronchial DiseasesRespiratory Tract DiseasesDigestive System DiseasesEndocrine System DiseasesCarcinoma, BronchogenicSkin DiseasesSkin and Connective Tissue DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Michael Meyers, MD, PhD

    Syndax Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2016

First Posted

September 13, 2016

Study Start

August 24, 2016

Primary Completion

March 13, 2017

Study Completion

March 13, 2017

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Data will be reviewed throughout the study by the sponsor, Contract Research Organization (CRO) assisting with Serious Adverse Event (SAE) management, and routine monitoring to safeguard the interests of trial patients and to assess the safety of the interventions administered during the trial.

Locations

US(1)