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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01685138




Registration number
NCT01685138
Ethics application status
Date submitted
4/09/2012
Date registered
14/09/2012

Titles & IDs
Public title
LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
Scientific title
A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
Secondary ID [1] 0 0
2012-003474-36
Secondary ID [2] 0 0
CLDK378A2203
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 - LDK378

Experimental: LDK378 (Ceritinib) - Participants on this arm took oral LDK378 750 mg once daily.


Treatment: Drugs: LDK378
LDK378/Ceritinib was supplied as 150 mg hard gelatin capsules and administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) by Investigator Assessment
Timepoint [1] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years
Secondary outcome [1] 0 0
ORR by Blinded Independent Review Committee (BIRC)
Timepoint [1] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years
Secondary outcome [2] 0 0
Duration of Response (DOR) as Per Investigator
Timepoint [2] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years
Secondary outcome [3] 0 0
Duration of Response (DOR) as Per BIRC
Timepoint [3] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years
Secondary outcome [4] 0 0
Disease Control Rate (DCR) as Per Investigator and BIRC
Timepoint [4] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years
Secondary outcome [5] 0 0
Time to Response (TTR) as Per Investigator
Timepoint [5] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug
Secondary outcome [6] 0 0
Time to Response (TTR) as Per BIRC
Timepoint [6] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years
Secondary outcome [7] 0 0
Overall Intracranial Response Rate (OIRR) as Per Investigator
Timepoint [7] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years
Secondary outcome [8] 0 0
Overall Intracranial Response Rate (OIRR) as Per BIRC
Timepoint [8] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years
Secondary outcome [9] 0 0
Progression-free Survival (PFS) Per Investigator and BIRC
Timepoint [9] 0 0
every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years
Secondary outcome [10] 0 0
Overall Survival (OS)
Timepoint [10] 0 0
Time from the date of first dose of LDK378 to the date of death due to any cause up to 5 years

Eligibility
Key inclusion criteria
Key Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC that carried an ALK rearrangement, as per the FDA-approved Vysis ALK break-apart FISH assay (Abbott Molecular Inc.)
* Age 18 years or older at the time of informed consent.
* Patients must have NSCLC that had progressed during or after the last chemotherapy regimen received prior to the first dose of LDK378, if chemotherapy was received
* Patients must have been chemotherapy-naive or had received 1-3 lines of cytotoxic chemotherapy to treat their locally advanced or metastatic NSCLC
* Patients must have had a tumor tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
* Patients must have recovered from all toxicities related to prior anticancer therapies to grade = 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who were not allowed to participate in the study.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Prior treatment with crizotinib, or any other ALK inhibitor investigational agent, for NSCLC
* Patients with known hypersensitivity to any of the excipients of LDK378.
* Patients with symptomatic central nervous system (CNS) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
* History of carcinomatous meningitis.
* Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
* Clinically significant, uncontrolled heart disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 2
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
20/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/01/2018
Sample size
Target
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - St Leonards
Recruitment hospital [2] 0 0
Novartis Investigative Site - Franston
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3199 - Franston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Belgium
State/province [5] 0 0
Genk
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Saskatchewan
Country [9] 0 0
France
State/province [9] 0 0
Saint Herblain cedex
Country [10] 0 0
Hong Kong
State/province [10] 0 0
Hong Kong
Country [11] 0 0
Italy
State/province [11] 0 0
AV
Country [12] 0 0
Italy
State/province [12] 0 0
GE
Country [13] 0 0
Italy
State/province [13] 0 0
MI
Country [14] 0 0
Italy
State/province [14] 0 0
TO
Country [15] 0 0
Japan
State/province [15] 0 0
Aichi
Country [16] 0 0
Japan
State/province [16] 0 0
Chiba
Country [17] 0 0
Japan
State/province [17] 0 0
Fukuoka
Country [18] 0 0
Japan
State/province [18] 0 0
Hyogo
Country [19] 0 0
Japan
State/province [19] 0 0
Osaka
Country [20] 0 0
Japan
State/province [20] 0 0
Shizuoka
Country [21] 0 0
Japan
State/province [21] 0 0
Tokyo
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Gyeonggi Do
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Korea
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
Norway
State/province [26] 0 0
Oslo
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Chelyabinsk
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
Russian Federation
State/province [29] 0 0
St-Petersburg
Country [30] 0 0
Singapore
State/province [30] 0 0
Singapore
Country [31] 0 0
Spain
State/province [31] 0 0
Andalucia
Country [32] 0 0
Spain
State/province [32] 0 0
Catalunya
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Sweden
State/province [34] 0 0
Stockholm
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taiwan ROC
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taiwan, ROC
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taichung
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei
Country [39] 0 0
Thailand
State/province [39] 0 0
Hat Yai
Country [40] 0 0
Thailand
State/province [40] 0 0
Bangkok
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Colchester
Country [42] 0 0
United Kingdom
State/province [42] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01685138