NCT02197247 - Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 4, 2014

Primary Completion Date

July 9, 2015

Study Completion Date

May 26, 2021

Conditions

Non Small Cell Lung Cancer

Interventions

PROCEDURE

Pharmacokinetic sampling - AZD9291

Blood sampling to measure AZD9291

DRUG

Rifampicin

Rifampicin (CYP inducer) 600mg taken once daily from Day 29 to Day 49 (Part A)

DRUG

AZD9291 tablet dosing

Part A: AZD9291 80mg tablet taken daily from Days 1 to 77. Part B: AZD9291 80mg tablet taken daily for 12 months.

PROCEDURE

Pharmacokinetic sampling - rifampicin

Blood sampling to measure rifampicin levels

PROCEDURE

Pharmacokinetic sampling - AZ5140 and AZ7550

Blood samples to measure levels of AZ5140 and AZ7550

Trial Locations (18)

112

Research Site, Taipei

10002

Research Site, Taipei

13620

Research Site, Seongnam-si

28040

Research Site, Madrid

28041

Research Site, Madrid

28046

Research Site, Madrid

29010

Research Site, Málaga

30322

Research Site, Atlanta

41013

Research Site, Seville

48202

Research Site, Detroit

1066 CX

Research Site, Amsterdam

6229 HX

Research Site, Maastricht

03722

Research Site, Seoul

06351

Research Site, Seoul

08041

Research Site, Barcelona

08908

Research Site, L'Hospitalet de Llobregat

CF14 2TL

Research Site, Cardiff

M20 4BX

Research Site, Manchester