Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Multi-center, Randomized Open Label 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)
Verified date | February 2022 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 306 |
Est. completion date | March 6, 2020 |
Est. primary completion date | June 16, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Novartis Investigative Site | Auckland | |
Australia | Novartis Investigative Site | Grafton | Auckland |
Austria | Novartis Investigative Site | Wien | |
Austria | Novartis Investigative Site | Wien | |
Belgium | Novartis Investigative Site | Edegem | |
Brazil | Novartis Investigative Site | Barretos | SP |
Brazil | Novartis Investigative Site | Itajai | SC |
Brazil | Novartis Investigative Site | Natal | RN |
Brazil | Novartis Investigative Site | Passo Fundo | RS |
Brazil | Novartis Investigative Site | Porto Alegre | RS |
Brazil | Novartis Investigative Site | Sao Paulo | SP |
Bulgaria | Novartis Investigative Site | Sofia | |
Canada | Novartis Investigative Site | Edmonton | Alberta |
Canada | Novartis Investigative Site | Hamilton | Ontario |
Canada | Novartis Investigative Site | Ottawa | Ontario |
Canada | Novartis Investigative Site | Toronto | Ontario |
Colombia | Novartis Investigative Site | Monteria | |
Czechia | Novartis Investigative Site | Brno | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Koeln | |
Germany | Novartis Investigative Site | Regensburg | Bavaria |
Germany | Novartis Investigative Site | Wuerzburg | |
Greece | Novartis Investigative Site | Athens | GR |
Greece | Novartis Investigative Site | Athens | |
India | Novartis Investigative Site | Bangalore | Karnataka |
India | Novartis Investigative Site | Delhi | |
India | Novartis Investigative Site | Hyderabad | Andhra Pradesh |
India | Novartis Investigative Site | Kolkata | West Bengal |
India | Novartis Investigative Site | Nashik | Maharashtra |
Italy | Novartis Investigative Site | Aviano | PN |
Italy | Novartis Investigative Site | Bergamo | BG |
Italy | Novartis Investigative Site | Bologna | BO |
Italy | Novartis Investigative Site | Brescia | BS |
Italy | Novartis Investigative Site | Meldola | FC |
Italy | Novartis Investigative Site | Milano | MI |
Italy | Novartis Investigative Site | Milano | MI |
Italy | Novartis Investigative Site | Novara | |
Italy | Novartis Investigative Site | Roma | RM |
Italy | Novartis Investigative Site | San Giovanni Rotondo | FG |
Italy | Novartis Investigative Site | Verona | VR |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Korea, Republic of | Novartis Investigative Site | Seoul | |
Lebanon | Novartis Investigative Site | Ashrafieh | |
Malaysia | Novartis Investigative Site | Kuching | Sarawak |
Malaysia | Novartis Investigative Site | Pulau Pinang | |
Netherlands | Novartis Investigative Site | Nieuwegein | |
Poland | Novartis Investigative Site | Gdansk | |
Poland | Novartis Investigative Site | Konin | |
Poland | Novartis Investigative Site | Tarnobrzeg | |
Russian Federation | Novartis Investigative Site | St Petersburg | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Madrid | |
Spain | Novartis Investigative Site | Pamplona | Navarra |
Spain | Novartis Investigative Site | San Sebastian | Pais Vasco |
Spain | Novartis Investigative Site | Sevilla | Andalucia |
Taiwan | Novartis Investigative Site | Taichung | |
Taiwan | Novartis Investigative Site | Taipei | |
Taiwan | Novartis Investigative Site | Taoyuan | |
Thailand | Novartis Investigative Site | Bangkok | THA |
Thailand | Novartis Investigative Site | Bangkok | |
Thailand | Novartis Investigative Site | Hat Yai | Songkla |
Turkey | Novartis Investigative Site | Talas / Kayseri | |
United Kingdom | Novartis Investigative Site | Newcastle Upon Tyne | Newcastle |
United Kingdom | Novartis Investigative Site | Wirral | Merseyside |
United States | Essex Oncology of North Jersey PA SC | Belleville | New Jersey |
United States | Highlands Oncology Group | Fayetteville | Arkansas |
United States | Greenville Health System SC | Greenville | South Carolina |
United States | Goshen Center for Cancer Care IU Health - SC | Indianapolis | Indiana |
United States | Loma Linda University | Loma Linda | California |
United States | Maryland Oncology Hematology, P.A. SC-2 | Rockville | Maryland |
United States | Utah Cancer Specialists Dept.of Utah Cancer Spec. (3) | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czechia, Germany, Greece, India, Italy, Korea, Republic of, Lebanon, Malaysia, Netherlands, Poland, Russian Federation, Spain, Taiwan, Thailand, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentration of ceritinib | Pharmacokinetics (PK) parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F | Study Day 22 | |
Secondary | Safety profile | Gastrointestinal (GI) Adverse Events (AEs), all Serious Advers Events (AEs), vital signs, electrocardiograms (ECGs) and laboratory abnormalities | The primary analysis will be based on data from all patients, up to the time at which all randomized patients have completed at least 12 weeks of ceritinib treatment or have discontinued study treatment, whichever is earlier. | |
Secondary | Plasma concentration of ceritinib | PK parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F | Study Day 1 | |
Secondary | Objective response rate (ORR) | Recist v1.1; Cycle = 21 days | Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease. | |
Secondary | Duration of response (DOR) | Recist v1.1 | Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease. |
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