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

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

November 14, 2014

Primary Completion Date

March 24, 2015

Study Completion Date

January 24, 2023

Conditions
Advanced Non Small Cell Lung CancerAdvanced (Inoperable) Non Small Cell Lung Cancer
Interventions
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.

Trial Locations (13)

21079

Research Site, Dijon

28040

Research Site, Madrid

28041

Research Site, Madrid

28050

Research Site, Madrid

41013

Research Site, Seville

44805

Research Site, Saint-Herblain

69373

Research Site, Lyon

03722

Research Site, Seoul

05505

Research Site, Seoul

SE1 9RT

Research Site, London

M20 4BX

Research Site, Manchester

NE7 7DN

Research Site, Newcastle upon Tyne

SM2 5PT

Research Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY