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Cancer patients get continued access to promising targeted therapy

NCT ID NCT03194893

Disease control Sponsor: Hoffmann-La Roche 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 ongoing treatment with alectinib or crizotinib to about 200 adults with ALK- or RET-positive cancer who were already benefiting from these drugs in a previous Roche trial. The main goal is to monitor safety and side effects as patients continue therapy after their original study ends. Participants must have been enrolled in a prior Roche-sponsored alectinib study and still be getting clinical benefit from the treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

50 people

The number who actually took part.

Started

Jul 2017

Finished

Sep 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Participants enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible * Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form (eCRF) * For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of study drug * For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of \< 1% per year during the treatment period and for at least 3 months after the last dose of study drug. Exclusion Criteria: * Evidence of lack of clinical benefit in parent trial during the screening phase of this rollover study * Permanent discontinuation of alectinib or crizotinib for any reason during the parent study or before first dose of study drug in the rollover study * Evidence of an adverse event for which the parent protocol stipulates permanent discontinuation * Pregnant or breastfeeding women * Ongoing serious adverse event that has not resolved to baseline level or Grade ≤1 prior to first dose of study treatment in the rollover study * Treatment interruption for more than 21 days due to an adverse event since the last administration of alectinib or crizotinib in the parent trial. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator * Administration of strong/potent cytochrome P450 (CYP) 3A inhibitors or inducers within 14 days prior to the first dose of treatment on this study and while on treatment with crizotinib * Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; these conditions should be discussed with the participant before trial entry

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Conditions

The condition(s) this trial relates to.

multiple endocrine neoplasia type 2A neoplasm non-small cell lung carcinoma RET fusion positive cancer

As listed by the trial registrant

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

Neoplasms

Contacts and locations

Locations

  • Adana Ac?badem Hospital Oncology Department

    Adana, 01130, Turkey (Türkiye)

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

    Perugia, Umbria, 06132, Italy

  • Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1

    Rome, Lazio, 00151, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50139, Italy

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31059, France

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Georges François Leclerc

    Dijon, 21000, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • City Clinical Oncology Hospital

    Moscow, Moscow Oblast, 143423, Russia

  • Ege University Medical Faculty

    Izmir, 35040, Turkey (Türkiye)

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

    Moscow, Moscow Oblast, 115478, Russia

  • Groupe Hospitalier Sud - Hôpital Haut Lévêque

    Pessac, 33600, France

  • Hacettepe Uni Medical Faculty Hospital

    S?hhiye, Ankara, 06100, Turkey (Türkiye)

  • Hopital Pontchaillou - CHU de Rennes

    Rennes, 35033, France

  • Hopital Robert Schuman

    Vantoux, 57070, France

  • Hospital Universitari Dexeus - Grupo Quironsalud

    Barcelona, 08028, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Irccs Centro Di Riferimento Oncologico (CRO)

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Istanbul Uni Capa Medical Faculty

    Istanbul, 34093, Turkey (Türkiye)

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114, United States

  • Queen Elizabeth Hospital Department of Clinical Oncology

    Kowloon, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • University ?linic of headaches

    Moscow, Moscow Oblast, 121467, Russia

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

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