At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Pharmacokinetic sampling - AZD9291, AZD9291 tablet dosing, and 3 other interventions for Non Small Cell Lung Cancer. Completed, enrolled 44 participants across 13 sites in 4 countries.
Detailed 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 rosuvastatin, following multiple oral dosing of AZD9291 in the 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 as a single agent until: disease progression; they are no longer deriving clinical benefit; or any other reason.
Study Details
Timeline
Interventions
Blood sampling to measure AZD9291
Part A: AZD9291 80mg tablet taken from Days 4 to 35. Part B: AZD9291 80mg tablet taken daily for 12 months.
Rosuvastatin (BCRP substrate) 20mg taken once daily on Days 1 and 32 (Part A) .
Blood sampling to measure rosuvastatin levels
Blood samples to measure levels of AZ5140 and AZ7550