Study to assess the effect of AZD9291 on the blood levels of Rosuvastatin, in patients with EGFRm+ non-small cell lung cancer

Study identifier:D5160C00019

ClinicalTrials.gov identifier:NCT02317016

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Rosuvastatin (a Sensitive BCRP Substrate) 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

AZD9291 tablet dosing, Rosuvastatin

Sex

All

Actual Enrollment

44

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 10 Mar 2015
Primary Completion Date: 11 Jul 2015
Study Completion Date: 22 May 2018

Study design

Allocation: N/A
Endpoint Classification: Pharmacokinetics
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria