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Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.

NCT01193257 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1099

Last updated 2018-12-19

Study results available
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Summary

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy

Conditions

Interventions

DRUG

Orteronel

Orteronel tablets

DRUG

Prednisone

Prednisone tablets

DRUG

Orteronel Placebo

Orteronel placebo-matching tablets

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-15
Primary Completion
2013-05-16
Completion
2016-02-29

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01193257 on ClinicalTrials.gov