Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer

NCT01942837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2022-10-24

Study results available
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Summary

This research study is evaluating a drug called enzalutamide in metastatic castration resistant prostate cancer. Enzalutamide is already FDA approved for metastatic castration resistant prostate cancer after treatment with chemotherapy.

The purpose of this study is to analyze features of tumor specimens sampled prior to therapy and at disease progression to determine why patients respond or stop responding to treatment with Enzalutamide.

Prior chemotherapy is not a requirement of this trial.

Conditions

Interventions

DRUG

Enzalutamide

Enzalutamide, formerly known as MDV3100, is a rationally-designed second generation AR inhibitor which functions by blocking several steps in the AR signaling cascade. Enzalutamide competitively binds the AR with great potency. Additionally, enzalutamide inhibits nuclear translocation of activated AR and inhibits the association of activated AR with DNA.

Sponsors & Collaborators

Principal Investigators

  • Mary-Ellen Taplin, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-13
Primary Completion
2021-12-31
Completion
2022-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01942837 on ClinicalTrials.gov