A 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 9, 2026 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Alectinib; Drug: Crizotinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Chao Family Comprehensive Cancer CenterOrange, California
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts
- Centre Francois BaclesseCaen
- Centre Georges François LeclercDijon
- Centre Oscar LambretLille
- Centre Leon BerardLyon
- Groupe Hospitalier Sud - Hôpital Haut LévêquePessac
- Hopital Pontchaillou - CHU de RennesRennes
- CHU de Toulouse - Hôpital LarreyToulouse
- Hopital Robert SchumanVantoux
- Queen Mary HospitalHong Kong
- Queen Elizabeth Hospital Department of Clinical OncologyKowloon
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2026. Always confirm current availability with the study team.