Non Small Cell Lung Cancer Clinical Trial
Official title:
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
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.
n/a
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