A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Simvastatin (a Sensitive CYP3A4 Substrate) in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

Trial Profile

A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Simvastatin (a Sensitive CYP3A4 Substrate) in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Jun 2017

At a glance

  • Drugs Osimertinib (Primary) ; Simvastatin
  • Indications Non-small cell lung cancer
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca
  • Most Recent Events

    • 07 Jun 2016 Results from this trial and other trial (NCT02317016)presented at the 52nd Annual Meeting of the American Society of Clinical Oncology
    • 16 May 2016 Planned End Date changed from 1 Apr 2016 to 1 Jan 2018.
    • 12 Mar 2016 Results assessing impact of disease and treatment response on DDI presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
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