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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Nov 2018

At a glance

  • Drugs Apalutamide (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms SPARTAN
  • Sponsors Aragon Pharmaceuticals; Janssen Pharmaceutical KK
  • Most Recent Events

    • 16 Nov 2018 According to a Janssen Pharmaceuticals media release, based on the data from this trial, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Apalutamide, for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
    • 14 Nov 2018 Results of an analysis from PROSPER and SPARTAN studies, presented at the 21st Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 23 Sep 2018 Planned End Date changed from 29 Aug 2019 to 30 Nov 2021.
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