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Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a Tablet Formulation in Patients With Non-Small Cell Lung Cancer

NCT02163733 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-01-22

Study results available
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Summary

This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow patients further access to AZD9291 and will provide for additional safety data collection.

Part A is a randomised, open-label, 2 treatment period crossover study in which patients will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time (approximately 0800) in each of 2 treatment periods (once immediately following a high fat meal \[fed\], and once in the fasted state \[fasted\]), with a washout period of 9 days between doses.

Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2 \[TP 2\] has been collected). Additional patients may be enrolled to allow for at least 30 evaluable patients

Conditions

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

Interventions

DRUG

AZD9291 tablets

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

PROCEDURE

Pharmacokinetic sampling - AZD9291

Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.

OTHER

Dietary Fasted

Fasted from 10 hours prior to dosing with 80mg AZD9291 tablet and 4 hours after dosing

OTHER

Dietary High Fat

Allocated breakfast prior to dosing with 80mg AZD9291 tablet

PROCEDURE

Pharmacokinetic sampling - AZ5140 and AZ7550

Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.

Sponsors & Collaborators

Principal Investigators

  • Serban Ghiorghiu, MSD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE

Eligibility

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

Timeline & Regulatory

Start
2014-11-14
Primary Completion
2015-03-24
Completion
2023-01-24

Countries

  • France
  • South Korea
  • Spain
  • United Kingdom

Study Locations

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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 NCT02163733 on ClinicalTrials.gov