Conditions: Non Small Cell Lung Cancer
Keywords: oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, simvastatin, EGFR genes
Allocation: NA | Intervention model: 
Enrollment: 52
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291.

Interventions: intervention 1: Pharmacokinetic sampling - AZD9291 intervention 2: Simvastatin intervention 3: AZD9291 tablet dosing intervention 4: Pharmacokinetic sampling - simvastatin intervention 5: Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention descriptions: intervention 1: Blood sampling to measure AZD9291 intervention 2: Simvastatin (CYP substrate) 40mg taken once daily on Days 1 and 31 (Part A) intervention 3: AZD9291 80mg tablet taken from Days 3 to 32. (Part B) AZD9291 80mg tablet taken daily for 12 months. intervention 4: Blood sampling to measure simvastatin levels intervention 5: Blood samples to measure levels of AZ5140 and AZ7550

Protocol document: