NCT03829930

Combination of Entinostat and Enzalutamide in Advanced Prostate Cancer

A Phase I Study of Entinostat in Combination With Enzalutamide for Treatment of Patients With Castration-Resistant Prostate Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: George Washington University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and tolerability of Entinostat in combination with Enzalutamide in metastatic castrate resistant prostate cancer

Detailed description

This study is designed to determine the safety and tolerability of Entinostat with Enzalutamide for treatment of patients with castration-resistant prostate cancer. There will be two dose levels of Entinostat in combination with same dose of Enzalutamide. Patients will be followed during treatment and 1 month post discontinuation.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Entinostat	Entinostat is formulated for oral administration. A food effect is evident for entinostat; exposure is significantly reduced when entinostat is administered with a high fat meal. Accordingly, entinostat is to be administered on an empty stomach, at least 1 hour before and 2 hours after a meal. Entinostat tablets should not be split, crushed, or chewed. Consult the individual clinical protocols for specific dosing instructions. Dose level 1: 3mg PO weekly. Dose level 2: 5mg PO weekly.
DRUG	Enzalutamide	Dose level 1: 160 mg PO daily. Dose level 2: 160 mg PO daily.

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2019-02-04
• Last updated: 2021-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study