D5160C00009 - Phase I, Open Label, PK, NSCLC (Food Effect)

• Research type

  Research Study

• Full title

  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

• IRAS ID

  159402

• Contact name

  Elizabeth Ruth Plummer

• Contact email

  Ruth.Plummer@newcastle.ac.uk / ruth.plummer@newcastle.ac.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2014-001556-37

• Clinicaltrials.gov Identifier

  NCT02163733

• Research summary

  This is a 2 part study in patients with non small cell lung cancer (NSCLC) that is caused by changes in a protein called Epidermal Growth Factor Receptor (EGFR). This protein can be altered by a change (mutation) to its genetic code. Patients who have NSCLC with a EGFR mutation can be treated by specific drugs called EGFR tyrosine kinase inhibitors (EGFR TKIs). Unfortunately, after a period of treatment with EGFR TKIs, tumours will no longer respond to this treatment. AZD9291 hopes to benefit those patients whose cancer has progressed despite previous treatment with EGFR TKIs.

  Part A will determine the effect food has on the PK (Pharmacokinetic) of AZD9291; how the body absorbs, breaks down and removes AZD9291 through levels of study drug in the blood depending on whether it's taken on a full or emplty stomach. Part A will be split into 2 treatment groups; Fed and Fasted. Participants will be in Part A for 15 days (following screening) and will participate in both treatment groups.

  Part B will determine how well AZD9291 is tolerated by allowing participants further access to AZD9291 after the PK phase, until such time as their disease progresses, the Investigator believes they are no longer benefitting from treatment, or they stop taking AZD9291 for another reason. Participants will be in Part B for at least 12 months (unless they withdraw).

  This study is Open-label which means that both the participant and investigators/ site study team will know which treatment the participant is receiving. Part A of the study is randomised which means the participants will be assigned to one of the treatment groups at random.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  14/SC/1251

• Date of REC Opinion

  10 Oct 2014

• REC opinion

  Favourable Opinion