Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC
Status:
Completed
Trial end date:
2021-05-26
Target enrollment:
Participant gender:
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 rifampicin on the pharmacokinetic (PK) parameters of AZD9291
and metabolites AZ5104 and AZ7550 following multiple oral dosing of both rifampicin and
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 who complete Part A will be able
to enter part B, and continue to receive AZD9291 80 mg once daily until: disease progression;
they are no longer deriving clinical benefit; or any other reason.