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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)

NCT02157883 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-11-19

Study results available
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Summary

This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy. Part A will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if they and the Investigator deem it appropriate, until such time as their disease progresses, the Investigator believes they are no longer deriving clinical benefit, or they stop taking AZD9291 for any other reason

Conditions

  • Advanced Non Small Cell Lung Cancer
  • Advanced (Inoperable) Non Small Cell Lung Cancer

Interventions

PROCEDURE

Pharmacokinetic sampling

Blood samples taken pre and post dosing with AZD9291+/- itraconazole

DRUG

AZD9291

AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.

DRUG

Itraconazole

Itraconazole tablets: 2x100mg bd, Part A days 6 to 19 only

Sponsors & Collaborators

Principal Investigators

  • Serban Ghiorghiu, MSD · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-06
Primary Completion
2015-04-03
Completion
2023-05-17

Countries

  • United States
  • Belgium
  • Netherlands
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157883 on ClinicalTrials.gov