A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

May 19, 2026 updated by: Hoffmann-La Roche

A Multicenter, International, Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer

The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who are deriving continued clinical benefit from alectinib or crizotinib in the parent trial at the time of parent trial closure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Dijon, France, 21000
        • Centre Georges François Leclerc
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Leon Berard
      • Pessac, France, 33600
        • Groupe Hospitalier Sud - Hôpital Haut Lévêque
      • Rennes, France, 35033
        • Hopital Pontchaillou - CHU de Rennes
      • Toulouse, France, 31059
        • CHU de Toulouse - Hôpital Larrey
      • Vantoux, France, 57070
        • Hopital Robert Schuman
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Kowloon, Hong Kong
        • Queen Elizabeth Hospital Department of Clinical Oncology
  • Italy
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Irccs Centro Di Riferimento Oncologico (CRO)
    • Lazio
      • Rome, Lazio, Italy, 00151
        • Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1
    • Tuscany
      • Florence, Tuscany, Italy, 50139
        • Azienda Ospedaliero-Universitaria Careggi
    • Umbria
      • Perugia, Umbria, Italy, 06132
        • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
  • Poland
      • Gda?sk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
  • Russia
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 143423
        • City Clinical Oncology Hospital
      • Moscow, Moscow Oblast, Russia, 115478
        • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
      • Moscow, Moscow Oblast, Russia, 121467
        • University ?linic of headaches
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08028
        • Hospital Universitari Dexeus - Grupo Quironsalud
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01130
        • Adana Ac?badem Hospital Oncology Department
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul Uni Capa Medical Faculty
      • Izmir, Turkey (Türkiye), 35040
        • Ege University Medical Faculty
      • S?hhiye, Ankara, Turkey (Türkiye), 06100
        • Hacettepe Uni Medical Faculty Hospital
  • United States
    • California
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Alectinib
Participants will receive alectinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
Drug: Alectinib
Alectinib capsules 600 mg twice a day (BID) orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.
Experimental: Crizotinib
Participants will receive crizotinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
Drug: Crizotinib
Crizotinib capsules 250 mg BID orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest
Time Frame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
An AE is considered any unfavorable and unintended sign, symptom, or disease associated with use of study drug, whether or not considered related to study drug. Preexisting conditions that worsened during study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug is reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Adverse events of special interest are cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate transaminase (AST) in combination with either an elevated bilirubin or clinical jaundice and suspected transmission of an infectious agent by study drug.
From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters
Time Frame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Selected safety laboratory parameters include alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, alkaline phosphatase (ALP), and blood creatine phosphokinase (CPK). Any treatment-emergent abnormal laboratory result accompanied by clinical symptoms or leading to a change in study medication or requiring a change in concomitant therapy is considered clinically significant.
From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number and Causes of Death Occurring on Study
Time Frame: From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
Once a patient has permanently discontinued study drug and completed the safety follow-up visit, no further survival data will be collected.
From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BO39694
  • 2017-000207-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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