Study identifier:D5160C00012
ClinicalTrials.gov identifier:NCT02157883
EudraCT identifier:2014-001557-16
CTIS identifier:N/A
A Phase I, Open-label, Non-randomised Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of a Single Oral Dose of AZD9291 in Patients with EGFRm Positive NSCLC Whose Disease has Progressed on an EGFR TKI
Advanced Non Small Cell Lung Cancer
Phase 1
No
AZD9291, Itraconazole
All
39
Interventional
18 Years - 99 Years
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics
Intervention Model: -
Masking: Open Label
Primary Purpose: Other
Verified 01 Feb 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD9291 alone, AZD9291+itraconozole Sequential treatments of AZD9291 alone followed by AZD9291+itraconazole, with a washout period in between. | Procedure/Surgery: Pharmacokinetic sampling Blood samples taken pre and post dosing with AZD9291+/- itraconazole Drug: AZD9291 AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months. Drug: Itraconazole Itraconazole tablets: 2x100mg bd, Part A days 6 to 19 only |