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)
Checked against the public recordLast updated Feb 9, 2022 · Source: ClinicalTrials.gov
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
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.
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.