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)

Completed · Phase 1

Conditions studied: Non-Small Cell Lung Cancer

In brief

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)

Key facts

Study ID

NCT02299505

Run by

Novartis Pharmaceuticals

People needed

306

Starts

2015-04-09

Expected to finish

2020-03-06

Last updated by the study team

2022-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Loma Linda University — Loma Linda, California, United States
• Goshen Center for Cancer Care IU Health - SC — Indianapolis, Indiana, United States
• Maryland Oncology Hematology, P.A. SC-2 — Rockville, Maryland, United States
• Essex Oncology of North Jersey PA SC — Belleville, New Jersey, United States
• Greenville Health System SC — Greenville, South Carolina, United States
• Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) — Salt Lake City, Utah, United States
• Novartis Investigative Site — Grafton, Auckland, Australia
• Novartis Investigative Site — Auckland, Australia
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Edegem, Belgium
• Novartis Investigative Site — Natal, Rio Grande do Norte, Brazil
• Novartis Investigative Site — Passo Fundo, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
• Novartis Investigative Site — Itajaí, Santa Catarina, Brazil
• Novartis Investigative Site — Barretos, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Sofia, Bulgaria
• Novartis Investigative Site — Edmonton, Alberta, Canada
• Novartis Investigative Site — Hamilton, Ontario, Canada
• Novartis Investigative Site — Ottawa, Ontario, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Montería, Colombia
• Novartis Investigative Site — Brno, Czechia
• Highlands Oncology Group — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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