MedTrace Logo

Combination of Entinostat and Enzalutamide in Advanced Prostate Cancer

NCT03829930 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-08-02

No results posted yet for this study

Summary

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

Conditions

  • Prostate Adenocarcinoma

Interventions

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.

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Principal Investigators

  • Jianquig Lin, MD · George Washington Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-09-01
Completion
2020-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829930 on ClinicalTrials.gov