Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer
NCT01942837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2022-10-24
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, 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
-
Medivation, Inc.
collaborator INDUSTRY - lead OTHER
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
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