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)
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)
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Feb 9, 2022 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: ceritinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology GroupFayetteville, Arkansas
- Loma Linda UniversityLoma Linda, California
- Goshen Center for Cancer Care IU Health - SCIndianapolis, Indiana
- Maryland Oncology Hematology, P.A. SC-2Rockville, Maryland
- Essex Oncology of North Jersey PA SCBelleville, New Jersey
- Greenville Health System SCGreenville, South Carolina
- Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)Salt Lake City, Utah
- Novartis Investigative SiteGrafton, Auckland
- Novartis Investigative SiteAuckland
- Novartis Investigative SiteVienna
- Novartis Investigative SiteVienna
- Novartis Investigative SiteEdegem
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 9, 2022. Always confirm current availability with the study team.