drugset / Trial / NCT02820961

Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

NCT02820961

Phase 1 Completed 61 enrolled Syndax Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the effect of exemestane on the pharmacokinetics (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer. Additionally, this study will evaluate the safety and tolerability of entinostat in combination with exemestane, and assess the effectiveness of entinostat in combination with exemestane in terms of best overall response and overall survival.

Timeline

Start
2016-06-29
Primary completion
2018-09-10
Completion
2021-07-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Entinostat Small molecule
Comparator Exemestane Small molecule