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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Syndax Pharmaceuticals
• Treatments: Aromatase Inhibitors; Entinostat; Exemestane

Criteria

Inclusion Criteria:

• Postmenopausal female patients

• Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis and have locally recurrent or metastatic disease that has progressed to where the patient is a candidate to receive exemestane as determined by the Investigator

• Patients receiving palliative radiation at the non-target lesions must be clinically stable prior to receiving the first dose of study treatment

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Patient must have acceptable, applicable laboratory requirements

• Patients may have a history of brain metastasis provided certain protocol criteria are met

• Able to understand and give written informed consent and comply with study procedures

Exclusion Criteria:

• Rapidly progressive or life-threatening metastases

• Inability to swallow oral medications or gastrointestinal (GI) malabsorption syndromes

• History of significant GI surgery as determined by Investigator

• A medical condition that precludes adequate study treatment or increases patient risk

• Currently enrolled in (or completed within 30 days prior to study drug administration) another investigational drug study