Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy

Trial Profile

Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jun 2018

At a glance

  • Drugs Enzalutamide (Primary)
  • Indications Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms AFFIRM
  • Sponsors Medivation; Pfizer
  • Most Recent Events

    • 14 Mar 2018 Status changed from active, no longer recruiting to completed.
    • 10 Feb 2018 Results of post hoc analysis evaluating the hepatic effects of enzalutamide versus comparators in controlled castration-resistant prostate cancer trials (NCT0121299; NCT00974311; NCT01664923; NCT01288911) presented at the 2018 Genitourinary Cancers Symposium
    • 26 Jan 2018 The study has been completed in Austria (End date: 2017-11-02)
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