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Trial details
ASCEND 8-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)
Current status:
Approved
|
Date registered:
15/12/2020
Trial version(s)
History: 27/12/2019
Current: 27/12/2019
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Main Information
Primary registry identifying number
LBCTR2019121369
Protocol number
CLDK378A2112
MOH registration number
9537/ص
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
This study was previously submitted before LBCTR and still ongoing
Date of registration in national regulatory agency
22/10/2015
Primary sponsor
Novartis Pharma Services Inc
Primary sponsor: Country of origin
Novartis Pharma services Inc
Public title
ASCEND 8-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)
Acronym
Scientific 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)
Acronym
Brief summary of the study: English
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)
Brief summary of the study: Arabic
دراسة جزافيّة متعددة المراكز مفتوحة اللصاقة لتقييم التعرّض الجهازي لدواء سيريتينيب 450 ملغ المأخوذ مع وجبة قليلة الدهون وفعاليّته وسلامته ودواء سيريتينيب 600 ملغ المأخوذ مع وجبة قليلة الدهون مقارنة بدواء سيريتينيب 750 ملغ المأخوذ على معدة فارغة لدى مرضى بالغين مصابين بسرطان الرئة النقيلي غير ذي الخلايا الصغيرة، كيناز الورم اللمفي الكشمي المعاد ترتيبه (كيناز الورم اللمفي الكشمي الإيجابي)
Health conditions/problem studied: Specify
Metastatic non-small cell lung cancer (NSCLC)
Interventions: Specify
Drug: ceritinib •Experimental: ceritinib 450 mg with a low-fat meal Intervention: Drug: ceritinib •Experimental: ceritinib 600 mg with a low-fat meal Intervention: Drug: ceritinib •Active Comparator: ceritinib 750 mg on an empty stomach Intervention: Drug: ceritinib
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion: 1.Histologically or cytologically confirmed diagnosis of stage IIIB (and is not a candidate for definitive multimodality therapy) or IV ALK-positive NSCLC. 2.Patients may have received one prior treatment regimen with crizotinib (all other ALK inhibitors are excluded). 3.Patients may have received prior chemotherapy, biologic therapy, or other investigational agents. ALK inhibitors other than crizotinib are excluded. 4.Patient has a World Health Organization (WHO) performance status 0-2.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
Exclusion: 1.Prior treatment with an ALK inhibitor other than crizotinib. 2.History of carcinomatous meningitis. 3.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. 5. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months) 6. 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). 7. Patient has other severe, acute, or chronic medical conditions 8. Patient is currently receiving treatment with warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Pharmacokinetic
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Dose comparison
Study phase
1
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
LDK378 (ceritinib)
Type of IMP
Cell therapy
Pharmaceutical class
5-Chloro-2-N-{5-methyl-4-(piperidin-4-yl)-2-[(propan-2-yl)oxy]phenyl}-4-N-[2-(propane-2-sulfonyl)phenyl]pyrimidine-2,4-diamine
Therapeutic indication
The study population will consist of previously treated and treatment-naive adult patients with metastatic ALK-positive NSCLC.
Therapeutic benefit
Overall Response Rate (ORR) and Duration of Response (DOR)
Biospecimen retention
Samples with DNA**
Biospecimen description
Samples are being shipped to a central Lab
Target sample size
5
Actual enrollment target size
5
Date of first enrollment: Type
Actual
Date of first enrollment: Date
10/02/2016
Date of study closure: Type
Actual
Date of study closure: Date
01/07/2020
Recruitment status
Complete
Date of completion
23/10/2017
IPD sharing statement plan
No
IPD sharing statement description
not provided
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT02299505?term=ldk378&cntry=LB&draw=1&rank=4
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinical trials.gov
NCT02299505
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Marwan
Ghosn
Beirut
Lebanon
03-226842
marwanghosnmd@yahoo.com
Hotel Dieu De France
Scientific
Hind
Khairallah
Sinelfil
Lebanon
+961 1512002Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Fadi
El Karak
Beirut
Lebanon
03-061621
felkarak@yahoo.com
Bellevue Medical Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Marwan Ghosn
Hematology oncology
Approved
Bellevue Medical Center
Fadi El Karak
Hematology oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
25/09/2015
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Bellevue Medical Center
10/06/2016
Ghassan Maalouf
gmaalouf@bmc.com.lb
+961 (0) 1 682666 ext 7600
Countries of Recruitment
Name
Lebanon
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Colombia
Czech Republic
Germany
Greece
India
Italy
Malaysia
Netherlands
Turkey
United Kingdom
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Metastatic non-small cell lung cancer (NSCLC)
Bronchus or lung, unspecified (C34.9)
Metastatic non-small cell lung cancer (NSCLC)
Interventions
Intervention
Description
Keyword
ICF, Lab tests, Vital signs , radiology, ECG
ICF, Lab tests, Vital signs , radiology, ECG
ICF, Lab tests, Vital signs , radiology, ECG
Primary Outcomes
Name
Time points
Measure
Plasma concentration of ceritinib
Day 22
Day 22
Key Secondary Outcomes
Name
Time points
Measure
Safety profile
12 weeks
12 weeks
Plasma concentration of ceritinib
Day 1
Day 1
•Duration of response (DOR)
every 6 weeks
every 6 weeks
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Study Close out- CSR-IMP reconciliation
14/12/2020
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