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Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 on Days 1 and 8 Every Three Weeks (q3wk) in Non-Colorectal Cancer (Non-CRC) Patients

Trial Profile

Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 on Days 1 and 8 Every Three Weeks (q3wk) in Non-Colorectal Cancer (Non-CRC) Patients

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 May 2021

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At a glance

  • Drugs Lurbinectedin (Primary) ; Serotonin; Steroids
  • Indications Solid tumours
  • Focus Adverse reactions
  • Sponsors PharmaMar
  • Most Recent Events

    • 29 Apr 2021 Results (N=244), Pharmacokinetic-pharmacodynamic analyses of pooled data from phase I studies A-0015 and A-005, and phase II studies B001, B-002, and B-0038 published in the Journal of Clinical Pharmacology
    • 09 Aug 2018 Results of pooled data from six phase I and three phase II trials with lurbinectedin, were published in the Clinical Pharmacokinetics.
    • 20 Jan 2017 Results (Data cut off April 2013; n=21) assessing recommended phase II dose of lurbinectedin, published in the Investigational New Drugs

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