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A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

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Trial Profile

A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients With Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Alisertib (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Therapeutic Use

    • Most Recent Events

    • 19 Sep 2018 Primary endpoint (Six month progression free survival) has been met, as per the results published in the Clinical Cancer Research.
    • 19 Sep 2018 Primary endpoint (6 month radiographic progression free survival) has not been met, as per the results published in the Clinical Cancer Research
    • 19 Sep 2018 As per the results published in the Clinical Cancer Research, radiographic response rate was initially selected as the primary endpoint, the trial was amended after an interim analysis of the 1st 19 patients demonstrating limited responses but with clinical improvement and stable disease in patients with aggressive disease and limited treatment options. Based on recommendations of the steering committee, the primary endpoint was modified to 6 month radiographic progression free survival.
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