Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLC

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 osimertinib on the pharmacokinetic (PK) parameters of fexofenadine, following single and multiple oral dosing of osimertinib in a fasted state. Continuous Access will allow patients further access to osimertinib after the PK phase (Part A). All patients from Part A who completed treatment may continue to receive osimertinib 80 mg once daily until: they are no longer deriving clinical benefit; or any other reason

Timeline

Start

2017-03-02

Primary completion

2017-07-31

Completion

2022-10-11

Publications

• Calvo E, Lee JS, Kim SW, Moreno V, deCastro Carpeno J, Weilert D, Laus G, Mann H, Vishwanathan K. Modulation of Fexofenadine Pharmacokinetics by Osimertinib in Patients With Advanced EGFR-Mutated Non-Small Cell Lung Cancer. J Clin Pharmacol. 2019 Aug;59(8):1099-1109. doi: 10.1002/jcph.1403. Epub 2019 Mar 15.

Drugs

Indications