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An Open-label, Randomised, Phase I, Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

Trial Profile

An Open-label, Randomised, Phase I, Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses 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: 14 Nov 2018

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At a glance

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

    • 05 Oct 2018 Planned End Date changed from 31 Dec 2018 to 31 Dec 2019.
    • 18 Dec 2017 Planned end date changed from 4 Jan 2018 to 31 Dec 2018.
    • 26 Nov 2017 Results of pooled data from two phase1 trial assessing impact of food or gastric pH modification (omeprazole) on the exposure and safety/tolerability of osimertinib and its metabolites in patient with EGFR mutation positive advanced non-small lung cancer, were published in the Journal of Clinical Pharmacology.
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