RecruitingPHASE2, PHASE3INTERVENTIONAL

DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers

This study is looking at a medicine called alectinib. This medicine is already approved to treat certain types of lung cancer in adults, specifically when their cancer has a particular gene change known as ALK. Doctors now want to find out if alectinib could also be helpful for adults, children, and young people with other types of cancer that also have this same ALK gene change. The study is part of a bigger project called DETERMINE, which aims to find new uses for anti-cancer drugs by matching them to specific rare cancers or cancers with particular gene changes. If the results are good, the study team hopes to make this treatment available through the NHS for those who need it.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Cancer Research UK

Enrolment target

Start

18 Dec 2023

Estimated completion

01 Oct 2029

Haematological Malignancy Malignant Neoplasm Lymphoproliferative Disorders Neoplasms by Histologic Type Neoplasms by Site Cancer Anaplastic Large Cell Lymphoma Lymphoma Renal Cell Carcinoma Neuroblastoma Solid Tumour

What is this study about?

This study is all about a medicine called alectinib. You might have heard of it because it's already a standard treatment for some adults with a certain type of lung cancer. This means it has gone through strict tests and has been approved for use in the UK by the health authorities. Alectinib works by targeting a specific change in the cancer's genes, called an ALK mutation. Think of it like a key that only fits a very specific lock – in this case, the ALK gene change in cancer cells.

At the moment, doctors want to see if this 'key' can also unlock benefits for people with other types of cancer that also have this same ALK gene change. This could include rare cancers or even common cancers where this particular change is uncommon. The study includes adults, children, and young adults. If the study shows good results, the team hopes to work with the NHS to make sure this treatment can become available to patients who could benefit from it in the future through programmes like the Cancer Drugs Fund.

This study is part of a larger research effort called the DETERMINE programme. This programme is designed to find new ways to use existing cancer medicines for patients with rare cancers or cancers that have very specific gene changes. By carefully matching the right medicine to the right patient based on their cancer's unique features, they hope to open up new treatment options.

Key takeaways

This study tests a cancer drug for specific gene changes.
It's for different cancers, including rare types, with an 'ALK positive' change.
Alectinib is already used in some lung cancers.
The study includes adults, children, and young adults.
Regular checks and follow-up are part of participating.

Who may be eligible?

To join this study, the most important thing is that your cancer has a specific gene change called ALK. This is found using a detailed test. The study is open to both men and women, regardless of their age.

If you are a woman who could become pregnant, you would need to have a negative pregnancy test before starting the study. You would also need to agree to use a very effective method of contraception (birth control) throughout your time in the study and for three months after your last dose of the medicine. This is to make sure you don't become pregnant while taking the study drug.

If you are a man whose partner could become pregnant, you would need to agree to use a barrier method of contraception, like a condom, and your partner would also need to use an effective method of birth control. This is important for the safety of any potential pregnancy.

Quick self-check

Is my cancer 'ALK positive' based on a special gene test?
Am I willing to use effective birth control if I could get pregnant or cause a pregnancy?
Am I able to attend regular appointments for tests?
Do I understand that I would be followed up for two years after treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the first step is called 'pre-screening' where doctors decide if your cancer might be right for this study based on its specific features. If it looks promising, you'll enter the 'screening' phase. This involves biopsies and blood tests to confirm your cancer has the ALK gene change and to gather samples for research.

If you qualify, you'll start receiving the study medicine, alectinib. You'll continue taking this medicine for as long as it's helping you and you're not experiencing difficult side effects. You'll have regular blood tests during this time, both while you're on the treatment and when you finish it. After you stop taking the study medicine, the study team will keep in touch with you every three months for about two years to see how you're doing. The total duration of your participation, including follow-up, could be several years.

Potential risks and benefits

Taking part in this study could offer a potential benefit by giving you access to a treatment that targets your specific cancer's ALK gene change, which might not be available otherwise. While alectinib is approved for some lung cancers, its effects on other cancer types with the ALK gene change are still being investigated. As with all medicines, there can be side effects, and the study team will carefully monitor you for any unwanted effects. You'll receive regular check-ups to assess how you're feeling and how the medicine is affecting you. It's very important to remember that joining a study is always your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

Belfast City Hospital
Belfast, United Kingdom· Recruiting
University Hospital Birmingham
Birmingham, United Kingdom· Recruiting
Birmingham Children's Hospital
Birmingham, United Kingdom· Not yet recruiting
Bristol Royal Hospital for Children
Bristol, United Kingdom· Recruiting
Bristol Haematology and Oncology Centre
Bristol, United Kingdom· Recruiting
Addenbrooke's Hospital
Cambridge, United Kingdom· Recruiting
Velindre Cancer Centre
Cardiff, United Kingdom· Recruiting
Cardiff Children's Hospital
Cardiff, United Kingdom· Not yet recruiting
Western General Hospital
Edinburgh, United Kingdom· Recruiting
The Beatson Hospital
Glasgow, United Kingdom· Recruiting
Royal Hospital for Children Glasgow
Glasgow, United Kingdom· Recruiting
Leicester Royal Infirmary
Leicester, United Kingdom· Recruiting

+15 more sites — see the official record for the full list.

Common questions

What is an ALK positive cancer?

It means your cancer has a specific gene change called ALK, which the study medicine targets.

Will this drug cure my cancer?

This study is testing if alectinib will be useful. It's not guaranteed to cure your cancer, but it might help manage it.

What if I get side effects?

The study team will closely monitor you. If you experience uncomfortable side effects, they will help manage them, and you might stop the treatment if necessary.

Will I have to pay for the drug?

No, if you are part of a clinical trial, the study will provide the medication.

How long will I be in the study?

You'll take the medicine as long as it's helping, and then you'll be followed up for two years after that.

How to find out more

Aida Sarmiento Castro

determine@cancer.org.uk +44 207 242 0200 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.