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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02299505




Registration number
NCT02299505
Ethics application status
Date submitted
14/11/2014
Date registered
24/11/2014
Date last updated
25/08/2021

Titles & IDs
Public title
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)
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)
Secondary ID [1] 0 0
2014-004001-32
Secondary ID [2] 0 0
CLDK378A2112
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ceritinib

Experimental: 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.

Experimental: 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.

Active Comparator: 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)


Treatment: Drugs: ceritinib
The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma concentration of ceritinib - Pharmacokinetics (PK) parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
Timepoint [1] 0 0
Study Day 22
Secondary outcome [1] 0 0
Safety profile - Gastrointestinal (GI) Adverse Events (AEs), all Serious Advers Events (AEs), vital signs, electrocardiograms (ECGs) and laboratory abnormalities
Timepoint [1] 0 0
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 outcome [2] 0 0
Plasma concentration of ceritinib - PK parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
Timepoint [2] 0 0
Study Day 1
Secondary outcome [3] 0 0
Objective response rate (ORR) - Recist v1.1; Cycle = 21 days
Timepoint [3] 0 0
Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.
Secondary outcome [4] 0 0
Duration of response (DOR) - Recist v1.1
Timepoint [4] 0 0
Tumor assessments every 6 weeks until cycle 9. At least every 12 weeks thereafter until progressive disease.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Aucklan
Recruitment hospital [1] 0 0
Novartis Investigative Site - Grafton
Recruitment hospital [2] 0 0
Novartis Investigative Site - Auckland
Recruitment postcode(s) [1] 0 0
- Grafton
Recruitment postcode(s) [2] 0 0
- Auckland
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
Austria
State/province [8] 0 0
Wien
Country [9] 0 0
Belgium
State/province [9] 0 0
Edegem
Country [10] 0 0
Brazil
State/province [10] 0 0
RN
Country [11] 0 0
Brazil
State/province [11] 0 0
RS
Country [12] 0 0
Brazil
State/province [12] 0 0
SC
Country [13] 0 0
Brazil
State/province [13] 0 0
SP
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Sofia
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Colombia
State/province [17] 0 0
Monteria
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno
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Germany
State/province [19] 0 0
Bavaria
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Germany
State/province [20] 0 0
Berlin
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Germany
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Koeln
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Germany
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Wuerzburg
Country [23] 0 0
Greece
State/province [23] 0 0
GR
Country [24] 0 0
Greece
State/province [24] 0 0
Athens
Country [25] 0 0
India
State/province [25] 0 0
Andhra Pradesh
Country [26] 0 0
India
State/province [26] 0 0
Karnataka
Country [27] 0 0
India
State/province [27] 0 0
Maharashtra
Country [28] 0 0
India
State/province [28] 0 0
West Bengal
Country [29] 0 0
India
State/province [29] 0 0
Delhi
Country [30] 0 0
Italy
State/province [30] 0 0
BG
Country [31] 0 0
Italy
State/province [31] 0 0
BO
Country [32] 0 0
Italy
State/province [32] 0 0
BS
Country [33] 0 0
Italy
State/province [33] 0 0
FC
Country [34] 0 0
Italy
State/province [34] 0 0
FG
Country [35] 0 0
Italy
State/province [35] 0 0
MI
Country [36] 0 0
Italy
State/province [36] 0 0
PN
Country [37] 0 0
Italy
State/province [37] 0 0
RM
Country [38] 0 0
Italy
State/province [38] 0 0
VR
Country [39] 0 0
Italy
State/province [39] 0 0
Novara
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Korea
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Lebanon
State/province [42] 0 0
Ashrafieh
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Malaysia
State/province [43] 0 0
Sarawak
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Malaysia
State/province [44] 0 0
Pulau Pinang
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Netherlands
State/province [45] 0 0
Nieuwegein
Country [46] 0 0
Poland
State/province [46] 0 0
Gdansk
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Poland
State/province [47] 0 0
Konin
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Poland
State/province [48] 0 0
Tarnobrzeg
Country [49] 0 0
Russian Federation
State/province [49] 0 0
St Petersburg
Country [50] 0 0
Spain
State/province [50] 0 0
Andalucia
Country [51] 0 0
Spain
State/province [51] 0 0
Navarra
Country [52] 0 0
Spain
State/province [52] 0 0
Pais Vasco
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Spain
State/province [53] 0 0
Madrid
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
State/province [56] 0 0
Taoyuan
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Thailand
State/province [57] 0 0
Songkla
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Thailand
State/province [58] 0 0
THA
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Thailand
State/province [59] 0 0
Bangkok
Country [60] 0 0
Turkey
State/province [60] 0 0
Talas / Kayseri
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Merseyside
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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)
Trial website
https://clinicaltrials.gov/show/NCT02299505
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications