Study to assess the effect of rifampicin on blood levels and safety of AZD9291, in patients with EGFRm+ NSCLC

Study identifier:D5160C00013

ClinicalTrials.gov identifier:NCT02197247

EudraCT identifier:2014-001525-32

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of Rifampicin (a CYP3A4 Inducer) on the Pharmacokinetics of AZD9291 in Patients with EGFRm Positive NSCLC whose disease has Progressed on an EGFR TKI

Medical condition

Non Small Cell Lung Cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

Rifampicin, AZD9291 tablet dosing

Sex

All

Actual Enrollment

41

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 04 Dec 2014
Primary Completion Date: 09 Jul 2015
Study Completion Date: 26 May 2021

Study design

Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: -
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Jul 2022 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria