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Trial details
Trial details
CLDK378A2X01B Roll over study in patients with ALK postive malignancies
Current status:
Approved
|
Date registered:
13/08/2020
Trial version(s)
History: 09/01/2019
History: 09/01/2019
History: 09/01/2019
History: 09/01/2019
Current: 09/01/2019
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Main Information
Primary registry identifying number
LBCTR2019010182
Protocol number
CLDK378A2X01B
MOH registration number
53628/2018
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
27/12/2018
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
CLDK378A2X01B Roll over study in patients with ALK postive malignancies
Acronym
Scientific title
An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib
Acronym
Brief summary of the study: English
The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.
Brief summary of the study: Arabic
دراسة مرحلة رابعة مفتوحة اللصاقة ومتعددة المراكز وتكميليّة لدى مرضى مصابين بأورام خبيثة إيجابيّة كيناز الورم اللمفي الكشمي والذين أنجزوا دراسة سابقة رعتها نوفارتيس حول سيريتينيب (LDK378) وقرّر الباحث أنّهم يستفيدون من مواصلة العلاج بسيريتينيب
Health conditions/problem studied: Specify
Non Small Cell Lung Cancer
Interventions: Specify
Drug : Ceritinib ( Zykadia ) capsules
Key inclusion and exclusion criteria: Inclusion criteria
•Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment. •Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements. •Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures. •Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed via an independent trusted witness.
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
•Patient has been permanently and prematurely discontinued from ceritinib study treatment in the parent study due to any reason. •Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study. •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test. •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months afer stopping ceritinib treatment. •Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after stopping ceritinib and should not father a child for at least 3 months after the last dose of treatment.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
N/A: Single arm study
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
4
Study design: Purpose
Treatment
Study design: Assignment
Single
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
Albania, Argentina, Canada, United states, United Arab Emirates, Ukraine, Turkey, Switzerland, Saudi Arabia, Oman, Mexico , Malasia
Name of IMP
Zykadia
Type of IMP
Others
Type of IMP: Specify
Targeted Therapy
Pharmaceutical class
Ceritinib is a potent adenosine triphosphate (ATP)-competitive inhibitor of ALK kinase activity.
Therapeutic indication
patients with ALK positive malignancies Non small cell Lung Cancer
Therapeutic benefit
- To collect safety data: adverse events and serious adverse events - To evaluate clinical benefit as assessed by the investigator
Biospecimen retention
Samples without DNA
Biospecimen description
Local Lab tests to follow up on patients safety. No samples will be shipped outside Lebanon
Target sample size
1
Actual enrollment target size
1
Date of first enrollment: Type
Actual
Date of first enrollment: Date
26/03/2019
Date of study closure: Type
Actual
Date of study closure: Date
18/11/2021
Recruitment status
Complete
Date of completion
26/03/2019
IPD sharing statement plan
No
IPD sharing statement description
Not decided
Additional data URL
https://clinicaltrials.gov/ct2/show/NCT02584933?term=CLDK378A2X01B&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
ClinicalTrials.gov
NCT02584933
EUDRACT European Union Drug Regulating Authorities Clinical Trials
2015-001922-40
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
00961 1 613395
marwanghosnmd@yahoo.com
Hotel Dieu De France
Scientific
Hind
Khairallah
Beirut
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Dr Marwan Ghson
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
05/12/2018
Marwan Ghosn
marwanghosnmd@yahoo.com
00961 1 613395
Countries of Recruitment
Name
Lebanon
United States of America
Australia
Belgium
China
France
Germany
Italy
Russian Federation
Spain
Japan
Health Conditions or Problems Studied
Condition
Code
Keyword
Non Small Cell Lung Cancer
Malignant neoplasm of bronchus and lung (C34)
NSCLC
Interventions
Intervention
Description
Keyword
Reference Table 7.1 of protocol
Informed consent / patient history / drug administration / Lab tests
ICF/ IMP administration/ Lab tests
Primary Outcomes
Name
Time points
Measure
1.Number of Participants with Adverse Events as a Measure of Safety and Tolerability
[ Time Frame: Until no patients are left on study up to 5 years ]
up to 5 years
Key Secondary Outcomes
Name
Time points
Measure
To evaluate clinical benefit as assessed by
Proportion of patients with clinical benefit
Confirmation of clinical benfit of study treament
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
Bi-annual SUSARs LDK378
12/08/2020
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