Lung Cancer Clinical Trial

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)

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 ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)

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Full 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 vs 750 mg in the fasted state was assessed in subjects with ALK+ NSCLC following multiple oral daily dosing of ceritinib. Subjects were randomized in a 1:1:1 ratio to once daily doses of oral ceritinib (450 mg following a low-fat meal, 600 mg following a low-fat meal or ceritinib 750 mg administered on an empty stomach). Randomization was stratified by brain metastases at Screening (presence or absence) and by prior treatment (prior crizotinib use with ALK+ determined by Fluorescent in situ hybridization (FISH); crizotinib-naïve but could be previously treated with other systemic anti-cancer therapy with ALK+ determined by FISH, or treatment-naïve subjects with ALK+ by IHC).

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

306

Study ID:

NCT02299505

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 70 Locations for this study

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Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Loma Linda University
Loma Linda California, 92354, United States
Goshen Center for Cancer Care IU Health - SC
Indianapolis Indiana, 46202, United States
Maryland Oncology Hematology, P.A. SC-2
Rockville Maryland, 20850, United States
Essex Oncology of North Jersey PA SC
Belleville New Jersey, 07109, United States
Greenville Health System SC
Greenville South Carolina, 29615, United States
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
Salt Lake City Utah, 84106, United States
Novartis Investigative Site
Grafton Auckland, , Australia
Novartis Investigative Site
Auckland , , Australia
Novartis Investigative Site
Wien , 1210, Austria
Novartis Investigative Site
Wien , A-114, Austria
Novartis Investigative Site
Edegem , 2650, Belgium
Novartis Investigative Site
Natal RN, 59075, Brazil
Novartis Investigative Site
Passo Fundo RS, 99010, Brazil
Novartis Investigative Site
Porto Alegre RS, 90601, Brazil
Novartis Investigative Site
Itajai SC, 88301, Brazil
Novartis Investigative Site
Barretos SP, 14784, Brazil
Novartis Investigative Site
Sao Paulo SP, 01246, Brazil
Novartis Investigative Site
Sofia , 1303, Bulgaria
Novartis Investigative Site
Edmonton Alberta, T6G 1, Canada
Novartis Investigative Site
Hamilton Ontario, L8V 5, Canada
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Ottawa Ontario, K1H 8, Canada
Novartis Investigative Site
Toronto Ontario, M5G 2, Canada
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Monteria , , Colombia
Novartis Investigative Site
Brno , 65653, Czechia
Novartis Investigative Site
Regensburg Bavaria, 93053, Germany
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Berlin , 12351, Germany
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Koeln , 51109, Germany
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Wuerzburg , 97074, Germany
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Athens GR, 115 2, Greece
Novartis Investigative Site
Athens , GR145, Greece
Novartis Investigative Site
Hyderabad Andhra Pradesh, 500 0, India
Novartis Investigative Site
Bangalore Karnataka, 560 0, India
Novartis Investigative Site
Nashik Maharashtra, 42200, India
Novartis Investigative Site
Kolkata West Bengal, 70006, India
Novartis Investigative Site
Delhi , 110 0, India
Novartis Investigative Site
Bergamo BG, 24127, Italy
Novartis Investigative Site
Bologna BO, 40138, Italy
Novartis Investigative Site
Brescia BS, 25123, Italy
Novartis Investigative Site
Meldola FC, 47014, Italy
Novartis Investigative Site
San Giovanni Rotondo FG, 71013, Italy
Novartis Investigative Site
Milano MI, 20141, Italy
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Milano MI, 20162, Italy
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Aviano PN, 33081, Italy
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Roma RM, 00155, Italy
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Verona VR, 37126, Italy
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Novara , 28100, Italy
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Seoul Korea, 05505, Korea, Republic of
Novartis Investigative Site
Seoul , 03080, Korea, Republic of
Novartis Investigative Site
Seoul , 03722, Korea, Republic of
Novartis Investigative Site
Seoul , 06351, Korea, Republic of
Novartis Investigative Site
Ashrafieh , 16648, Lebanon
Novartis Investigative Site
Kuching Sarawak, 93586, Malaysia
Novartis Investigative Site
Pulau Pinang , 10990, Malaysia
Novartis Investigative Site
Nieuwegein , 3435 , Netherlands
Novartis Investigative Site
Gdansk , 80 95, Poland
Novartis Investigative Site
Konin , 62 50, Poland
Novartis Investigative Site
Tarnobrzeg , 39-40, Poland
Novartis Investigative Site
St Petersburg , 19734, Russian Federation
Novartis Investigative Site
Sevilla Andalucia, 41009, Spain
Novartis Investigative Site
Pamplona Navarra, 31008, Spain
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San Sebastian Pais Vasco, 20080, Spain
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Madrid , 28050, Spain
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Madrid , 28222, Spain
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Taichung , 40447, Taiwan
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Taipei , 110, Taiwan
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Taoyuan , 33305, Taiwan
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Hat Yai Songkla, 90110, Thailand
Novartis Investigative Site
Bangkok THA, 10330, Thailand
Novartis Investigative Site
Bangkok , 10700, Thailand
Novartis Investigative Site
Talas / Kayseri , 38039, Turkey
Novartis Investigative Site
Wirral Merseyside, CH63 , United Kingdom
Novartis Investigative Site
Newcastle Upon Tyne Newcastle, NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

306

Study ID:

NCT02299505

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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