CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
Enzalutamidedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01942837
NCT01942837Phase 2Completed

Phase II Trial of Enzalutamide for Castrate-resistant Prostate Cancer (CRPC) With Correlative Assessment of Androgen Receptor (AR) Signaling and Whole-exome and Transcriptome Sequencing

Dana-Farber Cancer Institute·interventional·Posted Sep 16, 2013·Updated Oct 24, 2022

In Brief

A Phase 2 clinical trial evaluating Enzalutamide for Metastatic Castration-resistant Prostate Cancer. Completed, enrolled 67 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedivation, Inc.

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 16, 2013
Enrollment StartSep 13, 2013
Primary CompletionDec 1, 2021
Study CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 12.8 years ago

Interventions

Enzalutamidedrug

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.