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Spots Global Cancer Trial Database for Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Serban Ghiorghiu, MSD

Affiliation: AstraZeneca

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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