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A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

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A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2022

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At a glance

  • Drugs Orteronel (Primary) ; Prednisone
  • Indications Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ELM-PC4
  • Sponsors Takeda; Takeda Oncology

    • Most Recent Events

    • 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
    • 02 May 2016 Results assessing possible correlations of early PSA response with rPFS and OS (n = 118) published in the European Journal of Cancer.
    • 30 Sep 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.

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