Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLC

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 2, 2017

Primary Completion Date

July 31, 2017

Study Completion Date

October 11, 2022

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

Fexofenadine tablet dosing

Fexofenadine (P-gp substrate) 120mg taken once daily on Days 1 in Treatment Period 1 and Day 1 and Day 39 in Treatment Period 2

DRUG

Osimertininb tablet dosing

Osimertininb 80 mg taken once daily on Day 1 and Days 4 to 41 in Treatment Period 2

Trial Locations (7)

13620

Research Site, Seongnam-si

28040

Research Site, Madrid

28046

Research Site, Madrid

28050

Research Site, Madrid

35033

Research Site, Rennes

41013

Research Site, Seville

05505

Research Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

AstraZeneca

INDUSTRY