For Healthcare Professionals

Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer

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About the study

This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow patients further access to AZD9291 and will provide for additional safety data collection. Part A is a randomised, open-label, 2 treatment period crossover study in which patients will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time (approximately 0800) in each of 2 treatment periods (once immediately following a high fat meal [fed], and once in the fasted state [fasted]), with a washout period of 9 days between doses. Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2 [TP 2] has been collected). Additional patients may be enrolled to allow for at least 30 evaluable patients
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

    EXCLUSION CRITERIA

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      Study Locations

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      How to Apply


      Contact the study center to learn if this study is a good match for you.
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      Study’s details


      Contition

      Advanced (Inoperable) Non Small Cell Lung Cancer,Advanced Non Small Cell Lung Cancer

      Age

      18+

      Phase

      Phase 1

      Participants needed

      38

      Est. Completion Date

      Dec 2022

      Treatment type

      Interventional


      Sponsor

      AstraZeneca

      ClinicalTrials.gov identifier

      NCT02163733

      Study number

      D5160C00009

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