Clinical Trial Details

CERTINIB with Low-fat Meal

Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken with a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)

Purpose/Objective

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Full Trial Details: ClinicalTrials.gov

Condition: Lung Cancer
Study Type: Interventional
Phase: Phase I
Study Start Date: 04/09/2015
Study Completion Date: 10/25/2018

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).

NCT Number

NCT02299505

Principal Investigator(s)

Nicholas Farrell, MD

Sponsor(s)

Novartis Pharmaceuticals

Participant Eligibility

• Age: 18 - No Maximum
• Gender: Male, Female