Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study

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

ClinicalTrials.gov Identifier: NCT02584933

Novartis Reference Number: CLDK378A2X01B

Last Update: Apr 19, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
ALK Positive Malignancies
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
252 participants
Start date 
Dec 11, 2015
Completion date 
Jan 31, 2023
Gender 
All
Age(s)
12 Years and older (Child, Adult, Older Adult)

Interventions

Drug
ceritinib
hard gelatin capsule or hard tablet for oral use up to 750 mg

Eligibility 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.

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 Locations

Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
Novartis Investigative Site
Recruiting
Auckland,
-
Australia
Belgium
Novartis Investigative Site
Recruiting
Leuven, 3000
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90610-000
Rio Grande Do Sul
Brazil
Novartis Investigative Site
Recruiting
Natal, 59075 740
RN
Brazil
Novartis Investigative Site
Recruiting
Barretos, 14784 400
Sao Paulo
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 01246 000
SP
Brazil
China
Novartis Investigative Site
Recruiting
Guangzhou, 51000
Guangdong
China
Novartis Investigative Site
Recruiting
Changchun, 130012
Jilin
China
Novartis Investigative Site
Recruiting
Beijing, 100039
-
China
Novartis Investigative Site
Recruiting
Guangzhou, 510060
-
China
France
Novartis Investigative Site
Recruiting
France, 94800
Villejuif
France
Novartis Investigative Site
Recruiting
Strasbourg Cedex, 67091
-
France
Italy
Novartis Investigative Site
Recruiting
Bergamo, 24127
BG
Italy
Novartis Investigative Site
Recruiting
Meldola, 47014
FC
Italy
Novartis Investigative Site
Recruiting
Monza, 20900
MB
Italy
Novartis Investigative Site
Recruiting
Milano, 20133
MI
Italy
Novartis Investigative Site
Recruiting
Milano, 20141
MI
Italy
Novartis Investigative Site
Recruiting
Modena, 41124
MO
Italy
Novartis Investigative Site
Recruiting
Perugia, 06129
PG
Italy
Novartis Investigative Site
Recruiting
Aviano, 33081
PN
Italy
Novartis Investigative Site
Recruiting
Bologna, 40138
-
Italy
Novartis Investigative Site
Recruiting
Novara, 28100
-
Italy
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 05505
Korea
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul, 03722
-
Korea, Republic of
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 115478
-
Russian Federation
Novartis Investigative Site
Recruiting
Saint Petersburg, 192148
-
Russian Federation
Novartis Investigative Site
Recruiting
St Petersburg, 197343
-
Russian Federation
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169610
-
Singapore
Taiwan
Novartis Investigative Site
Recruiting
Taichung, 40705
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 11217
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]