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Active, not recruitingNCT02584933Updated Sep 17, 2026

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

A Phase 4 interventional study of ceritinib in ALK Positive Malignancies, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 71 sites in 21 countries. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
233
Allocation
Not applicable
Ages
12 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • ALK Positive Malignancies

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Keywords

  • ALK
  • Malignancies
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 233 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
233 participants (actual)

Study arms

  • 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.

    Drug: ceritinib

Interventions

  • Drugceritinib

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

06

What researchers measure

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    To collect safety data: adverse events and serious adverse events

    Time frame: Until no patients are left on study up to 5 years

07

Study locations

71 sites
  • Highlands Oncology Group
    Fayetteville, Arkansas 72703, United States
  • Loma Linda University
    Loma Linda, California 92354, United States
  • University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
  • Maryland Oncology Hematology P A
    Rockville, Maryland 20850, United States
  • Essex Oncology of North Jersey PA
    Belleville, New Jersey 07109, United States
  • Novartis Investigative Site
    Melbourne, Victoria 3000, Australia
  • Novartis Investigative Site
    Auckland, 1023, Australia
  • Novartis Investigative Site
    Leuven, 3000, Belgium
  • Novartis Investigative Site
    Natal, Rio Grande do Norte 59075-740, Brazil
  • Novartis Investigative Site
    Porto Alegre, Rio Grande do Sul 90610-000, Brazil
  • Novartis Investigative Site
    Barretos, São Paulo 14784-400, Brazil
  • Novartis Investigative Site
    São Paulo, São Paulo 01246-000, Brazil
  • Novartis Investigative Site
    Sofia, 1303, Bulgaria
  • Novartis Investigative Site
    Guangzhou, Guangdong 510080, China
  • Novartis Investigative Site
    Guangzhou, Guangdong 510120, China
  • Novartis Investigative Site
    Changchun, Jilin 130012, China
  • Novartis Investigative Site
    Beijing, 100039, China
  • Novartis Investigative Site
    Guangzhou, 510060, China
  • Novartis Investigative Site
    Montería, 230004, Colombia
  • Novartis Investigative Site
    Brno, 656 53, Czechia
  • Novartis Investigative Site
    Paris, 75231, France
  • Novartis Investigative Site
    Paris, 75970, France
  • Novartis Investigative Site
    Saint-Herblain, 44805, France
  • Novartis Investigative Site
    Strasbourg, 67091, France
  • Novartis Investigative Site
    Villejuif, 94800, France
  • Novartis Investigative Site
    Regensburg, Bavaria 93053, Germany
  • Novartis Investigative Site
    Cologne, North Rhine-Westphalia 50937, Germany
  • Novartis Investigative Site
    Essen, 45147, Germany
  • Novartis Investigative Site
    Heidelberg, 69120, Germany
  • Novartis Investigative Site
    Würzburg, 97074, Germany
  • Novartis Investigative Site
    Hong Kong, 999077, Hong Kong
  • Novartis Investigative Site
    Bergamo, BG 24127, Italy
  • Novartis Investigative Site
    Bologna, BO 40138, Italy
  • Novartis Investigative Site
    Brescia, BS 25123, Italy
  • Novartis Investigative Site
    Meldola, FC 47014, Italy
  • Novartis Investigative Site
    Monza, MB 20900, Italy
  • Novartis Investigative Site
    Milan, MI 20133, Italy
  • Novartis Investigative Site
    Milan, MI 20141, Italy
  • Novartis Investigative Site
    Milan, MI 20162, Italy
  • Novartis Investigative Site
    Rozzano, MI 20089, Italy
  • Novartis Investigative Site
    Modena, MO 41124, Italy
  • Novartis Investigative Site
    Perugia, PG 06129, Italy
  • Novartis Investigative Site
    Aviano, PN 33081, Italy
  • Novartis Investigative Site
    Naples, 80131, Italy
  • Novartis Investigative Site
    Novara, 28100, Italy
  • Novartis Investigative Site
    Nagoya, Aichi-ken 4648681, Japan
  • Novartis Investigative Site
    Fukuoka, Fukuoka 8111395, Japan
  • Novartis Investigative Site
    Akashi, Hyōgo 6738558, Japan
  • Novartis Investigative Site
    Koto Ku, Tokyo 1358550, Japan
  • Novartis Investigative Site
    Beirut, 1100 2070, Lebanon
  • Novartis Investigative Site
    George Town, Pulau Pinang 10450, Malaysia
  • Novartis Investigative Site
    Kuching, Sarawak 93586, Malaysia
  • Novartis Investigative Site
    Gdansk, 80-214, Poland
  • Novartis Investigative Site
    Moscow, 115522, Russia
  • Novartis Investigative Site
    Saint Petersburg, 192148, Russia
  • Novartis Investigative Site
    Saint Petersburg, 197343, Russia
  • Novartis Investigative Site
    Singapore, 168583, Singapore
  • Novartis Investigative Site
    Seoul, 03080, South Korea
  • Novartis Investigative Site
    Seoul, 03722, South Korea
  • Novartis Investigative Site
    Seoul, 05505, South Korea
  • Novartis Investigative Site
    A Coruña, 15006, Spain
  • Novartis Investigative Site
    Barcelona, 08035, Spain
  • Novartis Investigative Site
    Madrid, 28046, Spain
  • Novartis Investigative Site
    Madrid, 28050, Spain
  • Novartis Investigative Site
    Málaga, 29010, Spain
  • Novartis Investigative Site
    Taichung, 40447, Taiwan
  • Novartis Investigative Site
    Taichung, 407219, Taiwan
  • Novartis Investigative Site
    Taipei, 10002, Taiwan
  • Novartis Investigative Site
    Taipei, 110, Taiwan
  • Novartis Investigative Site
    Taipei, 11217, Taiwan
  • Novartis Investigative Site
    Taoyuan, 33305, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02584933
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 23, 2015
Start date
Dec 11, 2015
Primary completion
Jun 9, 2027 (estimated)
Completion
Jun 9, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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