A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib
taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with
that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged
(ALK-positive) metastatic non-small cell lung cancer (NSCLC)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02299505.
This was an open-label, randomized, multi-center, parallel design, Phase I study in which
the systemic exposure, efficacy and safety of ceritinib administered at 450 mg or 600 mg
with a low-fat meal vs 750 mg in the fasted state was assessed in subjects with ALK+
NSCLC following multiple oral daily dosing of ceritinib. Subjects were randomized in a
1:1:1 ratio to once daily doses of oral ceritinib (450 mg following a low-fat meal, 600
mg following a low-fat meal or ceritinib 750 mg administered on an empty stomach).
Randomization was stratified by brain metastases at Screening (presence or absence) and
by prior treatment (prior crizotinib use with ALK+ determined by Fluorescent in situ
hybridization (FISH); crizotinib-naïve but could be previously treated with other
systemic anti-cancer therapy with ALK+ determined by FISH, or treatment-naïve subjects
with ALK+ by IHC).
Lead OrganizationNovartis Pharmaceuticals Corporation