NCT02157883 - Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 6, 2014

Primary Completion Date

April 3, 2015

Study Completion Date

May 17, 2023

Conditions

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

Interventions

PROCEDURE

Pharmacokinetic sampling

Blood samples taken pre and post dosing with AZD9291+/- itraconazole

DRUG

AZD9291

AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.

DRUG

Itraconazole

Itraconazole tablets: 2x100mg bd, Part A days 6 to 19 only

Trial Locations (16)

2650

Research Site, Edegem

9000

Research Site, Ghent

10002

Research Site, Taipei

11217

Research Site, Taipei

13620

Research Site, Seongnam-si

44106

Research Site, Cleveland

92123

Research Site, San Diego

1066 CX

Research Site, Amsterdam

6229 HX

Research Site, Maastricht

3015 GD

Research Site, Rotterdam

03080

Research Site, lJongno-gu

03722

Research Site, Seoul

05505

Research Site, Seoul

06351

Research Site, Seoul

SE1 9RT

Research Site, London

M20 4BX

Research Site, Manchester