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

April 1, 2026 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

233

Phase

  • Phase 4

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Auckland, Australia, 1023
        • Novartis Investigative Site
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Novartis Investigative Site
  • Belgium
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Brazil
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075 740
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Novartis Investigative Site
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784 400
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brazil, 01246 000
        • Novartis Investigative Site
  • Bulgaria
      • Sofia, Bulgaria, 1303
        • Novartis Investigative Site
  • China
      • Beijing, China, 100039
        • Novartis Investigative Site
      • Guangzhou, China, 510060
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510120
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130012
        • Novartis Investigative Site
  • Colombia
      • Montería, Colombia, 230004
        • Novartis Investigative Site
  • Czechia
      • Brno, Czechia, 656 53
        • Novartis Investigative Site
  • France
      • Paris, France, 75231
        • Novartis Investigative Site
      • Paris, France, 75970
        • Novartis Investigative Site
      • Saint-Herblain, France, 44805
        • Novartis Investigative Site
      • Strasbourg, France, 67091
        • Novartis Investigative Site
      • Villejuif, France, 94800
        • Novartis Investigative Site
  • Germany
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
      • Würzburg, Germany, 97074
        • Novartis Investigative Site
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Novartis Investigative Site
  • Italy
      • Milan, Italy, 20141
        • Novartis Investigative Site
      • Naples, Italy, 80131
        • Novartis Investigative Site
      • Novara, Italy, 28100
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italy, 24127
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
    • FC
      • Meldola, FC, Italy, 47014
        • Novartis Investigative Site
    • MB
      • Monza, MB, Italy, 20900
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20133
        • Novartis Investigative Site
      • Milan, MI, Italy, 20162
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italy, 41124
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italy, 06129
        • Novartis Investigative Site
    • PN
      • Aviano, PN, Italy, 33081
        • Novartis Investigative Site
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464 8681
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • Novartis Investigative Site
    • Hyōgo
      • Akashi, Hyōgo, Japan, 673-8558
        • Novartis Investigative Site
    • Tokyo
      • Koto Ku, Tokyo, Japan, 135-8550
        • Novartis Investigative Site
  • Lebanon
      • Beirut, Lebanon, 166830
        • Novartis Investigative Site
  • Malaysia
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Novartis Investigative Site
  • Poland
      • Gdansk, Poland, 80-214
        • Novartis Investigative Site
  • Russia
      • Moscow, Russia, 115522
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 192148
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197343
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 168583
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 03080
        • Novartis Investigative Site
      • Seoul, South Korea, 05505
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Novartis Investigative Site
  • Spain
      • A Coruña, Spain, 15006
        • Novartis Investigative Site
      • Barcelona, Spain, 08035
        • Novartis Investigative Site
      • Madrid, Spain, 28046
        • Novartis Investigative Site
      • Madrid, Spain, 28050
        • Novartis Investigative Site
      • Málaga, Spain, 29010
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taichung, Taiwan, 407219
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taipei, Taiwan, 110
        • Novartis Investigative Site
      • Taoyuan District, Taiwan, 33305
        • Novartis Investigative Site
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Maryland Oncology Hematology P A
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Essex Oncology of North Jersey PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
hard gelatin capsule or hard tablet for oral use up to 750 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until no patients are left on study up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2015

Primary Completion (Estimated)

June 9, 2027

Study Completion (Estimated)

June 9, 2027

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 21, 2015

First Posted (Estimated)

October 23, 2015

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDK378A2X01B
  • 2024-511040-58-00 (Registry Identifier: EU CT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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