Study to Assess the Effect of AZD9291 on the Blood Levels of Rosuvastatin, in Patients With EGFRm+ Non-small Cell Lung Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

March 10, 2015

Primary Completion Date

July 11, 2015

Study Completion Date

May 22, 2018

Conditions
Non Small Cell Lung Cancer
Interventions
PROCEDURE

Pharmacokinetic sampling - AZD9291

Blood sampling to measure AZD9291

DRUG

AZD9291 tablet dosing

Part A: AZD9291 80mg tablet taken from Days 4 to 35. Part B: AZD9291 80mg tablet taken daily for 12 months.

DRUG

Rosuvastatin

Rosuvastatin (BCRP substrate) 20mg taken once daily on Days 1 and 32 (Part A) .

PROCEDURE

Pharmacokinetic sampling - rosuvastatin

Blood sampling to measure rosuvastatin levels

PROCEDURE

Pharmacokinetic sampling - AZ5140 and AZ7550

Blood samples to measure levels of AZ5140 and AZ7550

Trial Locations (13)

22031

Research Site, Fairfax

28007

Research Site, Madrid

29010

Research Site, Málaga

33075

Research Site, Bordeaux

33076

Research Site, Bordeaux

34298

Research Site, Montpellier

35033

Research Site, Rennes

41013

Research Site, Seville

41071

Research Site, Seville

08036

Research Site, Barcelona

EC1A 7BE

Research Site, London

W1G 6AD

Research Site, London

M20 4BX

Research Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY