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Lifeline for ALK cancer patients: continued access to ceritinib

NCT ID NCT02584933

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study offers continued treatment with the drug ceritinib to people with ALK-positive cancers who were already benefiting from it in a previous Novartis study. The main goal is to track safety and side effects over time. About 233 participants will receive the drug as long as their doctor believes it helps them.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

233 people

The number who actually took part.

Started

Dec 2015

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm neuroblastoma, susceptibility to, 3

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALK positive malignancies

Contacts and locations

Locations

  • Essex Oncology of North Jersey PA

    Belleville, New Jersey, 07109, United States

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703, United States

  • Loma Linda University

    Loma Linda, California, 92354, United States

  • Maryland Oncology Hematology P A

    Rockville, Maryland, 20850, 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, 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

    Milan, 20141, 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, 811-1395, Japan

  • Novartis Investigative Site

    Akashi, Hyōgo, 673-8558, 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

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States