ALK Positive MalignanciesPhase 4NCT02584933
Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
A Phase 4 study testing ceritinib in people with ALK Positive Malignancies, run by Novartis Pharmaceuticals at 71 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- ALK Positive Malignancies
- What is being tested?
- ceritinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 71 sitesin 21 countries
- Study dates
- 11 Dec 2015to 9 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
71 sites in 21 countries.
71 sites in 21 countries
Italy14 sites
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Meldola, FC, 47014
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, MI, 20141
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Modena, MO, 41124
Novartis Investigative Site
Monza, MB, 20900
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Novara, 28100
Novartis Investigative Site
Perugia, PG, 06129
Novartis Investigative Site
Rozzano, MI, 20089
Taiwan6 sites
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taichung, 407219
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 110
Novartis Investigative Site
Taipei, 11217
Novartis Investigative Site
Taoyuan, 33305
United States5 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Essex Oncology of North Jersey PA
Belleville, New Jersey, 07109
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Loma Linda University
Loma Linda, California, 92354
Maryland Oncology Hematology P A
Rockville, Maryland, 20850
China5 sites
Novartis Investigative Site
Beijing, 100039
Novartis Investigative Site
Changchun, Jilin, 130012
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Novartis Investigative Site
Guangzhou, Guangdong, 510120
Novartis Investigative Site
Guangzhou, 510060
France5 sites
Novartis Investigative Site
Paris, 75231
Novartis Investigative Site
Paris, 75970
Novartis Investigative Site
Saint-Herblain, 44805
Novartis Investigative Site
Strasbourg, 67091
Novartis Investigative Site
Villejuif, 94800
Germany5 sites
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Regensburg, Bavaria, 93053
Novartis Investigative Site
Würzburg, 97074
Spain5 sites
Novartis Investigative Site
A Coruña, 15006
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Madrid, 28050
Novartis Investigative Site
Málaga, 29010
Brazil4 sites
Novartis Investigative Site
Barretos, São Paulo, 14784-400
Novartis Investigative Site
Natal, Rio Grande do Norte, 59075-740
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90610-000
Novartis Investigative Site
São Paulo, São Paulo, 01246-000
Japan4 sites
Novartis Investigative Site
Akashi, Hyōgo, 6738558
Novartis Investigative Site
Fukuoka, Fukuoka, 8111395
Novartis Investigative Site
Koto Ku, Tokyo, 1358550
Novartis Investigative Site
Nagoya, Aichi-ken, 4648681
Russia3 sites
Novartis Investigative Site
Moscow, 115522
Novartis Investigative Site
Saint Petersburg, 192148
Novartis Investigative Site
Saint Petersburg, 197343
South Korea3 sites
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 05505
Australia2 sites
Novartis Investigative Site
Auckland, 1023
Novartis Investigative Site
Melbourne, Victoria, 3000
Malaysia2 sites
Novartis Investigative Site
George Town, Pulau Pinang, 10450
Novartis Investigative Site
Kuching, Sarawak, 93586
About this study
Official 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
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.
- Conditions
- ALK Positive Malignancies
- Being tested
- ceritinib
- Keywords
- ALK, Malignancies
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceritinibDrug
hard gelatin capsule or hard tablet for oral use up to 750 mg
| Study group | Role | What they receive |
|---|---|---|
| ceritinib | Experimental | 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. Receives: Drug: ceritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To collect safety data: adverse events and serious adverse events
Measured: Until no patients are left on study up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start11 Dec 2015
- Primary completion9 Jun 2027 (estimated)
- Study completion9 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK Positive MalignanciesStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584933
- Sponsor's protocol ID
- CLDK378A2X01B
- Other IDs
- 2024-511040-58-00
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2015
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02584933
- Acronym / sponsor ID
- CLDK378A2X01B
- Conditions
- ALK Positive Malignancies
- Keywords
- ALK, Malignancies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2015 (actual)
- Primary completion
- 9 Jun 2027 (estimated)
- Study completion
- 9 Jun 2027 (estimated)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ceritinib | Experimental | Drug: ceritinibThe 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. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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 exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ceritinibhard gelatin capsule or hard tablet for oral use up to 750 mg | Drug | ceritinib |
Primary outcome
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
To collect safety data: adverse events and serious adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
71 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ceritinib in people with ALK Positive Malignancies, run by Novartis Pharmaceuticals at 71 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in Italy, Taiwan, United States, China, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.