At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Pharmacokinetic sampling, AZD9291, and 1 other intervention for Advanced Non Small Cell Lung Cancer and Advanced (Inoperable) Non Small Cell Lung Cancer. Completed, enrolled 39 participants across 16 sites in 6 countries.
Detailed Summary
This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy. Part A will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if they and the Investigator deem it appropriate, until such time as their disease progresses, the Investigator believes they are no longer deriving clinical benefit, or they stop taking AZD9291 for any other reason
Study Details
Timeline
Interventions
Blood samples taken pre and post dosing with AZD9291+/- itraconazole
AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.
Itraconazole tablets: 2x100mg bd, Part A days 6 to 19 only