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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02584933




Registration number
NCT02584933
Ethics application status
Date submitted
6/10/2015
Date registered
23/10/2015
Date last updated
3/07/2018

Titles & IDs
Public title
Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
Scientific title
An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib
Secondary ID [1] 0 0
CLDK378A2X01B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ALK Positive Malignancies 0 0
Condition category
Condition code

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

Experimental: ceritinib - The starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent ceritinib study at the time of the rollover.


Treatment: Drugs: ceritinib
hard gelatin capsule or hard tablet for oral use up to 750 mg

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

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability - To collect safety data: adverse events and serious adverse events
Timepoint [1] 0 0
Until no patients are left on study up to 5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [2] 0 0
Novartis Investigative Site - Auckland
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
- Auckland
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
China
State/province [3] 0 0
Guangdong
Country [4] 0 0
China
State/province [4] 0 0
Jilin
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Guangzhou
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Germany
State/province [8] 0 0
Essen
Country [9] 0 0
Germany
State/province [9] 0 0
Heidelberg
Country [10] 0 0
Hong Kong
State/province [10] 0 0
Hong Kong
Country [11] 0 0
Italy
State/province [11] 0 0
MB
Country [12] 0 0
Italy
State/province [12] 0 0
MI
Country [13] 0 0
Italy
State/province [13] 0 0
MO
Country [14] 0 0
Italy
State/province [14] 0 0
PG
Country [15] 0 0
Japan
State/province [15] 0 0
Aichi
Country [16] 0 0
Japan
State/province [16] 0 0
Fukuoka
Country [17] 0 0
Japan
State/province [17] 0 0
Hyogo
Country [18] 0 0
Japan
State/province [18] 0 0
Tokyo
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Korea
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Moscow
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Saint Petersburg
Country [23] 0 0
Singapore
State/province [23] 0 0
Singapore
Country [24] 0 0
Spain
State/province [24] 0 0
Andalucia
Country [25] 0 0
Spain
State/province [25] 0 0
Catalunya
Country [26] 0 0
Spain
State/province [26] 0 0
Galicia
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taichung
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taipei

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

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02584933
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02584933