Study to assess the effect of AZD9291 on the blood levels of Simvastatin in patients with EGFRm+ NSCLC

Study identifier:D5160C00014

ClinicalTrials.gov identifier:NCT02197234

EudraCT identifier:2014-002070-36

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Simvastatin (a Sensitive CYP3A4 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

Simvastatin, AZD9291 tablet dosing

Sex

All

Actual Enrollment

52

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 22 Dec 2014
Primary Completion Date: 30 Apr 2015
Estimated Study Completion Date: 31 Dec 2024

Study design

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

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria