Study identifier:D5160C00014
ClinicalTrials.gov identifier:NCT02197234
EudraCT identifier:2014-002070-36
CTIS identifier:N/A
A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Simvastatin (a Sensitive CYP3A4 Substrate) in Patients with EGFRm Positive NSCLC whose disease has Progressed on an EGFR TKI
Non Small Cell Lung Cancer
Phase 1
No
Simvastatin, AZD9291 tablet dosing
All
52
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: Pharmacokinetics
Intervention Model: -
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD9291 and simvastatin Sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291. | Procedure/Surgery: 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/Surgery: Pharmacokinetic sampling - simvastatin Blood sampling to measure simvastatin levels Procedure/Surgery: Pharmacokinetic sampling - AZ5140 and AZ7550 Blood samples to measure levels of AZ5140 and AZ7550 |