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)
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)
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-naÃ¯ve but could be previously treated with other systemic anti-cancer therapy with ALK+ determined by FISH, or treatment-naÃ¯ve subjects with ALK+ by IHC).
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 (CoumadinÂ®) or any other coumarin-derivative anticoagulants.
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There are 70 Locations for this study
Fayetteville Arkansas, 72703, United States
Loma Linda California, 92354, United States
Indianapolis Indiana, 46202, United States
Rockville Maryland, 20850, United States
Belleville New Jersey, 07109, United States
Greenville South Carolina, 29615, United States
Salt Lake City Utah, 84106, United States
Grafton Auckland, , Australia
Auckland , , Australia
Wien , 1210, Austria
Wien , A-114, Austria
Edegem , 2650, Belgium
Natal RN, 59075, Brazil
Passo Fundo RS, 99010, Brazil
Porto Alegre RS, 90601, Brazil
Itajai SC, 88301, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Sofia , 1303, Bulgaria
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8V 5, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Monteria , , Colombia
Brno , 65653, Czechia
Regensburg Bavaria, 93053, Germany
Berlin , 12351, Germany
Koeln , 51109, Germany
Wuerzburg , 97074, Germany
Athens GR, 115 2, Greece
Athens , GR145, Greece
Hyderabad Andhra Pradesh, 500 0, India
Bangalore Karnataka, 560 0, India
Nashik Maharashtra, 42200, India
Kolkata West Bengal, 70006, India
Delhi , 110 0, India
Bergamo BG, 24127, Italy
Bologna BO, 40138, Italy
Brescia BS, 25123, Italy
Meldola FC, 47014, Italy
San Giovanni Rotondo FG, 71013, Italy
Milano MI, 20141, Italy
Milano MI, 20162, Italy
Aviano PN, 33081, Italy
Roma RM, 00155, Italy
Verona VR, 37126, Italy
Novara , 28100, Italy
Seoul Korea, 05505, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Ashrafieh , 16648, Lebanon
Kuching Sarawak, 93586, Malaysia
Pulau Pinang , 10990, Malaysia
Nieuwegein , 3435 , Netherlands
Gdansk , 80 95, Poland
Konin , 62 50, Poland
Tarnobrzeg , 39-40, Poland
St Petersburg , 19734, Russian Federation
Sevilla Andalucia, 41009, Spain
Pamplona Navarra, 31008, Spain
San Sebastian Pais Vasco, 20080, Spain
Madrid , 28050, Spain
Madrid , 28222, Spain
Taichung , 40447, Taiwan
Taipei , 110, Taiwan
Taoyuan , 33305, Taiwan
Hat Yai Songkla, 90110, Thailand
Bangkok THA, 10330, Thailand
Bangkok , 10700, Thailand
Talas / Kayseri , 38039, Turkey
Wirral Merseyside, CH63 , United Kingdom
Newcastle Upon Tyne Newcastle, NE7 7, United Kingdom
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