Trials / Completed
CompletedNCT02833155
Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer
A Phase I and Pharmacokinetic Study to Evaluate Histone Deacetylase Inhibitor, Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Taizhou EOC Pharma Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and tolerance of entinostat administered orally as a single agent in a weekly dosing schedule. Additionally, this study will characterize the pharmacokinetics parameters in Chinese postmenopausal women with advanced breast cancer. And to define the profile of adverse events, including laboratory parameters in these subjects
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entinostat | Given PO |
| DRUG | Exemestane | Given PO |
Timeline
- Start date
- 2016-08-29
- Primary completion
- 2018-07-18
- Completion
- 2018-07-18
- First posted
- 2016-07-14
- Last updated
- 2019-05-07
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02833155. Inclusion in this directory is not an endorsement.