Study identifier:D5160C00019
ClinicalTrials.gov identifier:NCT02317016
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Rosuvastatin (a Sensitive BCRP Substrate) in Patients with EGFRm Positive NSCLC whose disease has Progressed on an EGFR TKI
Non Small Cell Lung Cancer
Phase 1
No
AZD9291 tablet dosing, Rosuvastatin
All
44
Interventional
18 Years - 99 Years
Allocation: N/A
Endpoint Classification: Pharmacokinetics
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jun 2018 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD9291 and rosuvastatin Sequential treatments of rosuvastatin alone followed by AZD9291 alone, followed by rosuvastatin + AZD9291. | Procedure/Surgery: Pharmacokinetic sampling - AZD9291 Blood sampling to measure AZD9291 Drug: AZD9291 tablet dosing Part A: AZD9291 80mg tablet taken from Days 4 to 35. Part B: AZD9291 80mg tablet taken daily for 12 months. Drug: Rosuvastatin Rosuvastatin (BCRP substrate) 20mg taken once daily on Days 1 and 32 (Part A) . Procedure/Surgery: Pharmacokinetic sampling - rosuvastatin Blood sampling to measure rosuvastatin levels Procedure/Surgery: Pharmacokinetic sampling - AZ5140 and AZ7550 Blood samples to measure levels of AZ5140 and AZ7550 |