drugset / Trial / NCT02833155

Entinostat in Chinese Postmenopausal Women Patients With Locally Recurrent or Metastatic Breast Cancer

NCT02833155

Phase 1 Completed 19 enrolled Taizhou EOC Pharma Co., Ltd.
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2016-08-29
Primary completion
2018-07-18
Completion
2018-07-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Entinostat Small molecule 3 mg Oral
Subject Entinostat Small molecule 5 mg Oral
Subject Entinostat Small molecule 7 mg Oral
Subject Exemestane Small molecule 25 mg

Indications