Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
NCT ID: NCT02584933
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
233 participants
INTERVENTIONAL
2015-12-11
2027-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
ceritinib
hard gelatin capsule or hard tablet for oral use up to 750 mg
Interventions
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ceritinib
hard gelatin capsule or hard tablet for oral use up to 750 mg
Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Loma Linda University
Loma Linda, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Maryland Oncology Hematology P A
Rockville, Maryland, United States
Essex Oncology of North Jersey PA
Belleville, New Jersey, United States
Novartis Investigative Site
Melbourne, Victoria, Australia
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Auckland, , Australia
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Leuven, , Belgium
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Natal, Rio Grande do Norte, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Sofia, , Bulgaria
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Guangzhou, Guangdong, China
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Guangzhou, Guangdong, China
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Changchun, Jilin, China
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Beijing, , China
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Guangzhou, , China
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Montería, , Colombia
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Brno, , Czechia
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Paris, , France
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Paris, , France
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Saint-Herblain, , France
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Strasbourg, , France
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Villejuif, , France
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Regensburg, Bavaria, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, , Germany
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Heidelberg, , Germany
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Würzburg, , Germany
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Hong Kong, , Hong Kong
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Bergamo, BG, Italy
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Bologna, BO, Italy
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Brescia, BS, Italy
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Meldola, FC, Italy
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Monza, MB, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Modena, MO, Italy
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Perugia, PG, Italy
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Aviano, PN, Italy
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Napoli, , Italy
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Novara, , Italy
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Nagoya, Aichi-ken, Japan
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Fukuoka, Fukuoka, Japan
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Akashi, Hyōgo, Japan
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Koto Ku, Tokyo, Japan
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Beirut, , Lebanon
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George Town, Pulau Pinang, Malaysia
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Kuching, Sarawak, Malaysia
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Gdansk, , Poland
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Singapore, , Singapore
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Seoul, Korea, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
Novartis Investigative Site
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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2024-511040-58-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLDK378A2X01B
Identifier Type: -
Identifier Source: org_study_id
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