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

NCT03194893 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: BO396942017-000207-24
• Study Type: interventional
• Target: 200
• Locations: 9 countries
• Sites: 29

Brief Summary

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.

Conditions

Neoplasms

Keywords

Non-small cell lung cancer (NSCLC); Anaplastic lymphoma kinase (ALK); Rearranged during transfection (RET); Alectinib; Crizotinib

Outcome Measures

Primary Outcomes (2)

• Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest

  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

  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 Outcomes (1)

• Number and Causes of Death Occurring on Study

  From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)

Study Arms (2)

Alectinib

EXPERIMENTAL

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

Crizotinib

EXPERIMENTAL

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

Interventions

Alectinib DRUG

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.

Alectinib

Crizotinib DRUG

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.

Crizotinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (29)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Centre Francois Baclesse

Caen, 14076, France

Location

Centre Georges François Leclerc

Dijon, 21000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Groupe Hospitalier Sud - Hôpital Haut Lévêque

Pessac, 33600, France

Location

Hopital Pontchaillou - CHU de Rennes

Rennes, 35033, France

Location

CHU de Toulouse - Hôpital Larrey

Toulouse, 31059, France

Location

Hopital Robert Schuman

Vantoux, 57070, France

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital Department of Clinical Oncology

Kowloon, Hong Kong

Location

Irccs Centro Di Riferimento Oncologico (CRO)

Aviano, Friuli Venezia Giulia, 33081, Italy

Location

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

Rome, Lazio, 00151, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, 50139, Italy

Location

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

Perugia, Umbria, 06132, Italy

Location

Uniwersyteckie Centrum Kliniczne

Gda?sk, 80-214, Poland

Location

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

Moscow, Moscow Oblast, 115478, Russia

Location

University ?linic of headaches

Moscow, Moscow Oblast, 121467, Russia

Location

City Clinical Oncology Hospital

Moscow, Moscow Oblast, 143423, Russia

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Dexeus - Grupo Quironsalud

Barcelona, 08028, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Adana Ac?badem Hospital Oncology Department

Adana, 01130, Turkey (Türkiye)

Location

Istanbul Uni Capa Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35040, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital

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

Location

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung; Multiple Endocrine Neoplasia Type 2a

Interventions

alectinib; Crizotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopyridines; Pyridines

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 21, 2017
• Study Start: July 5, 2017
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

HK (2); IT (4); US (2); RU (3); ES (3); PL (1); TU (4); KR (2); FR (8)