NCT02163733

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

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

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

Interventions

Type	Name	Description
DRUG	AZD9291 tablets	AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.
PROCEDURE	Pharmacokinetic sampling - AZD9291	Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.
OTHER	Dietary Fasted	Fasted from 10 hours prior to dosing with 80mg AZD9291 tablet and 4 hours after dosing
OTHER	Dietary High Fat	Allocated breakfast prior to dosing with 80mg AZD9291 tablet
PROCEDURE	Pharmacokinetic sampling - AZ5140 and AZ7550	Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.

Timeline

• Start date: 2014-11-14
• Primary completion: 2015-03-24
• Completion: 2023-01-24
• First posted: 2014-06-16
• Last updated: 2024-01-22
• Results posted: 2016-04-05

Locations

13 sites across 4 countries: France, South Korea, Spain, United Kingdom