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)

Study identifier:D5160C00012

ClinicalTrials.gov identifier:NCT02157883

EudraCT identifier:2014-001557-16

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral Dose of AZD9291 in Patients with EGFRm Positive NSCLC Whose Disease has Progressed on an EGFR TKI

Medical condition

Advanced Non Small Cell Lung Cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD9291, Itraconazole

Sex

All

Actual Enrollment

39

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 06 Nov 2014
Primary Completion Date: 03 Apr 2015
Study Completion Date: 17 May 2023

Study design

Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics
Intervention Model: -
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria