MedTrace Logo

Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC

NCT02197247 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-07-12

Study results available
· View outcomes & findings →

Summary

This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of rifampicin on the pharmacokinetic (PK) parameters of AZD9291 and metabolites AZ5104 and AZ7550 following multiple oral dosing of both rifampicin and AZD9291 in a fasted state.

Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will provide for additional safety data collection. All patients who complete Part A will be able to enter part B, and continue to receive AZD9291 80 mg once daily until: disease progression; they are no longer deriving clinical benefit; or any other reason.

Conditions

  • Non Small Cell Lung Cancer

Interventions

PROCEDURE

Pharmacokinetic sampling - AZD9291

Blood sampling to measure AZD9291

DRUG

Rifampicin

Rifampicin (CYP inducer) 600mg taken once daily from Day 29 to Day 49 (Part A)

DRUG

AZD9291 tablet dosing

Part A: AZD9291 80mg tablet taken daily from Days 1 to 77. Part B: AZD9291 80mg tablet taken daily for 12 months.

PROCEDURE

Pharmacokinetic sampling - rifampicin

Blood sampling to measure rifampicin levels

PROCEDURE

Pharmacokinetic sampling - AZ5140 and AZ7550

Blood samples to measure levels of AZ5140 and AZ7550

Sponsors & Collaborators

Principal Investigators

  • Serban Ghiorghiu, MSD · AstraZeneca

Study Design

Purpose
OTHER
Masking
NONE

Eligibility

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

Timeline & Regulatory

Start
2014-12-04
Primary Completion
2015-07-09
Completion
2021-05-26

Countries

  • United States
  • Netherlands
  • South Korea
  • Spain
  • 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 NCT02197247 on ClinicalTrials.gov