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

Completed · Phase 3

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID: NCT03194893
Run by: Hoffmann-La Roche
People needed: 50
Starts: 2017-07-05
Expected to finish: 2025-09-18
Last updated by the study team: 2026-06-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Chao Family Comprehensive Cancer Center — Orange, California, United States
Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
Centre Francois Baclesse — Caen, France
Centre Georges François Leclerc — Dijon, France
Centre Oscar Lambret — Lille, France
Centre Leon Berard — Lyon, France
Groupe Hospitalier Sud - Hôpital Haut Lévêque — Pessac, France
Hopital Pontchaillou - CHU de Rennes — Rennes, France
CHU de Toulouse - Hôpital Larrey — Toulouse, France
Hopital Robert Schuman — Vantoux, France
Queen Mary Hospital — Hong Kong, Hong Kong
Queen Elizabeth Hospital Department of Clinical Oncology — Kowloon, Hong Kong
Irccs Centro Di Riferimento Oncologico (CRO) — Aviano, Friuli Venezia Giulia, Italy
Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1 — Rome, Lazio, Italy
Azienda Ospedaliero-Universitaria Careggi — Florence, Tuscany, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia — Perugia, Umbria, Italy
Uniwersyteckie Centrum Kliniczne — Gda?sk, Poland
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" — Moscow, Moscow Oblast, Russia
University ?linic of headaches — Moscow, Moscow Oblast, Russia
City Clinical Oncology Hospital — Moscow, Moscow Oblast, Russia
Seoul National University Hospital — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Hospital del Mar — Barcelona, Spain
Hospital Universitari Dexeus - Grupo Quironsalud — Barcelona, Spain
Hospital Universitario La Paz — Madrid, Spain

Full record on ClinicalTrials.gov

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