Study identifier:D5160C00013
ClinicalTrials.gov identifier:NCT02197247
EudraCT identifier:2014-001525-32
CTIS identifier:N/A
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
Non Small Cell Lung Cancer
Phase 1
No
Rifampicin, AZD9291 tablet dosing
All
41
Interventional
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: -
Masking: Open Label
Primary Purpose: Other
Verified 01 Jul 2022 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Rifampicin and AZD9291 Sequential treatments of AZD9291 alone followed by AZD9291 +rifampicin, followed by AZD9291 alone. | Procedure/Surgery: Pharmacokinetic sampling - AZD9291 Blood sampling to measure AZD9291 Drug: Rifampicin Rifampicin (CYP inducer) 600mg taken once daily from Day 29 to Day 49 (Part A) Drug: AZD9291 tablet dosing Part A: AZD9291 80mg tablet taken daily from Days 1 to 77. Part B: AZD9291 80mg tablet taken daily for 12 months. Procedure/Surgery: Pharmacokinetic sampling - rifampicin Blood sampling to measure rifampicin levels Procedure/Surgery: Pharmacokinetic sampling - AZ5140 and AZ7550 Blood samples to measure levels of AZ5140 and AZ7550 |