CompletedPhase 3

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

United States, France, Hong Kong50 participantsStarted 2017-07-05

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

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

Trial details

NCT IDNCT03194893

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-18

View on ClinicalTrials.gov More Neoplasms trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

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