Trials / Completed
CompletedNCT02897778
Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors
A Phase 1 Cardiac Safety Study of Entinostat in Men and Women With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Syndax Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2016-08-24
- Primary completion
- 2017-03-13
- Completion
- 2017-03-13
- First posted
- 2016-09-13
- Last updated
- 2022-04-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02897778. Inclusion in this directory is not an endorsement.