NCT02197234 - Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 22, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

June 3, 2024

Conditions

Non Small Cell Lung Cancer

Interventions

PROCEDURE

Pharmacokinetic sampling - AZD9291

Blood sampling to measure AZD9291

DRUG

Simvastatin

Simvastatin (CYP substrate) 40mg taken once daily on Days 1 and 31 (Part A)

DRUG

AZD9291 tablet dosing

AZD9291 80mg tablet taken from Days 3 to 32. (Part B) AZD9291 80mg tablet taken daily for 12 months.

PROCEDURE

Pharmacokinetic sampling - simvastatin

Blood sampling to measure simvastatin levels

PROCEDURE

Pharmacokinetic sampling - AZ5140 and AZ7550

Blood samples to measure levels of AZ5140 and AZ7550

Trial Locations (16)

3000

Research Site, Leuven

13385

Research Site, Marseille

13620

Research Site, Seongnam-si

21079

Research Site, Dijon

28046

Research Site, Madrid

30322

Research Site, Atlanta

35033

Research Site, Rennes

41013

Research Site, Seville

44805

Research Site, Saint-Herblain

49055

Research Site, Angers

03080

Research Site, Seoul

03722

Research Site, Seoul

05505

Research Site, Seoul

06351

Research Site, Seoul

08916

Research Site, Badalona

08041

Research Site, Barcelona