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Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC

NCT02197234 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-11-20

Study results available
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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 AZD9291 on the pharmacokinetic (PK) parameters of simvastatin and simvastatin acid, following multiple oral dosing of 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 from Part A who completed treatment may 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

Simvastatin

Simvastatin (CYP substrate) 40mg taken once daily on Days 1 and 31 (Part A)

DRUG

AZD9291 tablet dosing

AZD9291 80mg tablet taken from Days 3 to 32. (Part B) AZD9291 80mg tablet taken daily for 12 months.

PROCEDURE

Pharmacokinetic sampling - simvastatin

Blood sampling to measure simvastatin 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

Allocation
NA
Purpose
TREATMENT
Masking
NONE

Eligibility

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

Timeline & Regulatory

Start
2014-12-22
Primary Completion
2015-04-30
Completion
2024-06-03

Countries

  • United States
  • Belgium
  • France
  • South Korea
  • Spain

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 NCT02197234 on ClinicalTrials.gov