Status:
COMPLETED
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)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ceriti...
Detailed Description
This was an open-label, randomized, multi-center, parallel design, Phase I study in which the systemic exposure, efficacy and safety of ceritinib administered at 450 mg or 600 mg with a low-fat meal v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2020
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT02299505
Start Date
April 9 2015
End Date
March 6 2020
Last Update
February 9 2022
Active Locations (73)
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1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Loma Linda University
Loma Linda, California, United States, 92354
3
Goshen Center for Cancer Care IU Health - SC
Indianapolis, Indiana, United States, 46202
4
Maryland Oncology Hematology, P.A. SC-2
Rockville, Maryland, United States, 20850