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)

• Status: Completed
• Trial end date: 2020-03-06
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ceritinib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a candidate for definitive multimodality therapy) or IV ALK-positive NSCLC.

• Patients may have received one prior treatment regimen with crizotinib (all other ALK inhibitors are excluded).

• Patients may have received prior chemotherapy, biologic therapy, or other investigational agents. ALK inhibitors other than crizotinib are excluded.

• Patient has a World Health Organization (WHO) performance status 0-2.

Exclusion Criteria:

• Prior treatment with an ALK inhibitor other than crizotinib.

• History of carcinomatous meningitis.

• Presence or history of a malignant disease other than an ALK-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years.

• Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months)

• Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).

• Patient has other severe, acute, or chronic medical conditions

• Patient is currently receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.