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A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral Dose of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

Trial Profile

A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral Dose of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 31 Jul 2019

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At a glance

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

    • 17 Jan 2019 Planned End Date changed from 31 Dec 2018 to 31 Dec 2019.
    • 07 Mar 2018 Planned End Date changed from 4 Jan 2018 to 31 Dec 2018.
    • 30 Jan 2018 Results of a study assessing effect of Itraconazole on the pharmacokinetics of Osimertinib published in the British Journal of Clinical Pharmacology
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