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A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF DAROLUTAMIDE (ODM-201) IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

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A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF DAROLUTAMIDE (ODM-201) IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2024

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At a glance

  • Drugs Darolutamide (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ARAMIS
  • Sponsors Bayer; Orion Pharma

    • Most Recent Events

    • 05 Jul 2024 Results assessing the extended safety and tolerability of darolutamide and the time-course profile of treatment-emergent adverse events (TEAEs) related to ARis and androgen-suppressive treatment, published in the Oncologist
    • 16 May 2024 According to a Bayer media release, post hoc analysis from this study will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, United States, from May 31-June 4, 2024.
    • 11 Nov 2023 Results pooled post hoc analysis from TITAN and 806 SPARTAN assessing efficacy, safety and wellbeing in older patients with advanced prostate cancer published in the British Journal of Cancer
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