An Open-label, Randomised, Phase I, Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI
Active, no longer recruiting
Phase of Trial: Phase I
Latest Information Update: 19 Jan 2018
At a glance
- Drugs Osimertinib (Primary)
- Indications Non-small cell lung cancer
- Focus Pharmacokinetics
- Sponsors AstraZeneca
- 18 Dec 2017 Planned end date changed from 4 Jan 2018 to 31 Dec 2018.
- 26 Nov 2017 Results of pooled data from two phase1 trial assessing impact of food or gastric pH modification (omeprazole) on the exposure and safety/tolerability of osimertinib and its metabolites in patient with EGFR mutation positive advanced non-small lung cancer, were published in the Journal of Clinical Pharmacology.
- 17 May 2016 Planned End Date changed from 1 Apr 2016 to 1 Jan 2018.