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Brief Title: Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC
Official Title: A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of Rifampicin (a CYP3A4 Inducer) on the Pharmacokinetics of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI
Study ID: NCT02197247
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 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Atlanta, Georgia, United States
Research Site, Detroit, Michigan, United States
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Amsterdam, , Netherlands
Research Site, Maastricht, , Netherlands
Research Site, Barcelona, , Spain
Research Site, L'Hospitalet de Llobregat, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Málaga, , Spain
Research Site, Sevilla, , Spain
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Cardiff, , United Kingdom
Research Site, Manchester, , United Kingdom
Name: Serban Ghiorghiu, MSD
Affiliation: AstraZeneca
Role: STUDY_DIRECTOR