A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Trial Profile

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Discontinued
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2017

At a glance

  • Drugs Orteronel (Primary) ; Prednisone
  • Indications Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ELM-PC5
  • Sponsors Takeda Oncology
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 06 Jun 2017 Results assessing a week 13 Circulating tumor cell prostate-specific antigen (PSA) endpoint relative to baseline in 5 prospective randomized phase 3 registration trials (n=5912, COU-AA-301, AFFIRM, ELM-PC-5, ELM-PC-4 and COMET-1 trials) presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
    • 17 May 2017 This trial has been completed in France (end date: 29 Feb 2016).
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