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 Oct 2017
At a glance
- Drugs Apalutamide (Primary)
- Indications Adenocarcinoma; Prostate cancer
- Focus Registrational; Therapeutic Use
- Acronyms SPARTAN
- Sponsors Aragon Pharmaceuticals; Janssen Pharmaceutical KK
- 11 Oct 2017 According to a Janssen media release, company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC). Submission was based on data from this trial.
- 23 Dec 2016 Planned End Date changed from 31 Aug 2019 to 1 Aug 2019.
- 20 Dec 2016 Planned primary completion date changed from 1 Dec 2016 to 1 Jun 2017.