drugset / Trial / NCT02299505

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)

NCT02299505

Phase 1 Completed 306 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

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)

Timeline

Start
2015-04-09
Primary completion
2016-06-16
Completion
2020-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceritinib Small molecule 450 mg Oral
Subject Ceritinib Small molecule 600 mg Oral
Subject Ceritinib Small molecule 750 mg Oral