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Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

NCT01995513 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 509

Last updated 2023-09-18

Study results available
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Summary

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

Conditions

Interventions

DRUG

Enzalutamide

160 mg by mouth once daily

DRUG

Abiraterone

1000 mg by mouth once daily

DRUG

Placebo for Enzalutamide

Sugar pill manufactured to mimic Enzalutamide 40 mg capsule

DRUG

Prednisone

5 mg by mouth twice daily

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

  • Medical Director · Medviation, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-22
Primary Completion
2016-11-15
Completion
2022-08-31

Countries

  • United States
  • Australia
  • Belgium
  • Denmark
  • Finland
  • France
  • Italy
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01995513 on ClinicalTrials.gov