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)
NCT ID: NCT02299505
Last Updated: 2022-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
306 participants
INTERVENTIONAL
2015-04-09
2020-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ceritinib 450 mg with a low-fat meal
Oral ceritinib QD (21 days/ cycle) at a dose of 450 mg (3×150 mg/capsule) administered in the morning immediately (within 30 minutes)following a low-fat meal.
ceritinib
The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration.
ceritinib 600 mg with a low-fat meal
Oral ceritinib QD (21 days/ cycle) at a dose of 600 mg (4×150 mg/capsule) administered in the morning immediately (within 30 minutes) following a low-fat meal.
ceritinib
The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration.
ceritinib 750 mg on an empty stomach
Oral ceritinib QD (21 days/ cycle) at a dose of 750 mg (5×150 mg/capsule) administered in the morning on an empty stomach (i.e., fasted from food and drink except water)
ceritinib
The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration.
Interventions
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ceritinib
The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
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
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Auckland, , Australia
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Vienna, , Austria
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Vienna, , Austria
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Edegem, , Belgium
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Natal, Rio Grande do Norte, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Itajaí, Santa Catarina, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Sofia, , Bulgaria
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Edmonton, Alberta, Canada
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montería, , Colombia
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Brno, , Czechia
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Regensburg, Bavaria, Germany
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Berlin, , Germany
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Cologne, , Germany
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Würzburg, , Germany
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Athens, GR, Greece
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Athens, , Greece
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Nashik, Maharashtra, India
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Kolkata, West Bengal, India
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Delhi, , India
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Bergamo, BG, Italy
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Bologna, BO, Italy
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Brescia, BS, Italy
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Meldola, FC, Italy
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San Giovanni Rotondo, FG, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Aviano, PN, Italy
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Roma, RM, Italy
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Verona, VR, Italy
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Novara, , Italy
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El Achrafiyé, Lebanon, Lebanon
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Kuching, Sarawak, Malaysia
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Pulau Pinang, , Malaysia
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Nieuwegein, , Netherlands
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Gdansk, , Poland
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Konin, , Poland
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Tarnobrzeg, , Poland
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Saint Petersburg, , Russia
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Seoul, Korea, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seville, Andalusia, Spain
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Donostia / San Sebastian, Basque Country, Spain
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Pamplona, Navarre, Spain
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Madrid, , Spain
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Madrid, , Spain
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Hat Yai, Changwat Songkhla, Thailand
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Bangkok, THA, Thailand
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Bangkok, , Thailand
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Talas / Kayseri, , Turkey (Türkiye)
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Metropolitan Borough of Wirral, Merseyside, United Kingdom
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Newcastle upon Tyne, Newcastle, United Kingdom
Countries
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Related Links
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Results for CLDK378A2112 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2014-004001-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLDK378A2112
Identifier Type: -
Identifier Source: org_study_id
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