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RecruitingPHASE2, PHASE3INTERVENTIONAL

DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patients With Cancers Harbouring MET Dysregulations

This study, called DETERMINE Treatment Arm 06, is exploring a medicine called capmatinib. Capmatinib is already used in the UK for certain lung cancers that have a specific genetic change. Now, doctors want to find out if it can also help adults with other types of cancer that have the same genetic change, or similar changes, in a gene called MET. The study aims to see if this treatment is effective in these other cancers. If the results are good, the study team hopes to work with the NHS to make this treatment more widely available. It's part of a larger research effort to match existing cancer drugs to more rare cancers or those with specific genetic features.

At a glance

Status
Recruiting
Phase
PHASE2, PHASE3
Sponsor
Cancer Research UK
Enrolment target
30
Start
19 Nov 2024
Estimated completion
01 Oct 2029

What is this study about?

This study is looking into a medicine called capmatinib. This drug is already used safely and effectively in the UK to treat certain types of lung cancer in adults. It works specifically for lung cancers that have a particular change in their genes, known as a METex14 skipping mutation. Think of it like this: some cancers have a 'switch' that's turned on by a faulty gene, and capmatinib is designed to turn that switch off.

Researchers now want to see if capmatinib can also be helpful for people with other kinds of cancer, not just lung cancer, especially if these other cancers also have similar genetic changes or alterations involving the MET gene. This is important because it could open up new treatment options for patients whose cancers might be harder to treat with standard methods, particularly rare cancers or very specific types of more common cancers.

The ultimate goal of this research is to discover new ways to treat cancer effectively. If capmatinib shows good results in this study for these other cancer types, the study team hopes to work with the NHS (National Health Service) and the Cancer Drugs Fund. This would help make sure that if the treatment is proven safe and effective, it could become available to more patients across the UK in the future.

Key takeaways

  • Tests if an existing cancer drug (capmatinib) can treat other cancers.
  • Focuses on cancers with specific genetic changes (MET dysregulations).
  • Trial aims to make new treatments available through the NHS if successful.
  • Participation involves taking the drug, regular checks, and follow-up.
  • You can leave the study at any time.
  • It's for adults aged 18 and over.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. Your cancer must have a specific genetic change involving something called the 'MET gene'. This means doctors would have identified a METex14 skipping mutation, MET amplification, MET fusion, or another MET activating mutation in your cancer cells using special tests. These tests are usually done on a sample of your cancer.

Beyond these main points, there are other detailed health requirements that need to be checked to make sure it's safe for you to take part. For women who could become pregnant, you'll need to have a negative pregnancy test and agree to use highly effective birth control during the study and for 7 days after your last dose of medication. For men with female partners who could become pregnant, you'll need to use a condom or avoid sexual activity during the study and for 7 days after your last dose, to avoid fathering a child.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Does your cancer have a 'MET gene' change (like METex14 skipping, MET amplification, etc.)?
  3. Are you willing to use effective birth control if you could become pregnant or father a child?
  4. Are you able to attend regular appointments and blood tests?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step involves your medical team looking at your cancer's genetic information to see if it matches the study requirements. If it does, you'll go through screening tests, including giving blood samples and possibly a biopsy, for research purposes. Once approved, you will start taking the study drug, capmatinib. You'll continue to take capmatinib until your cancer worsens, you experience side effects that are too difficult to manage, or you decide to stop participating. During your treatment, you'll have blood samples taken regularly, and another at the end of your treatment. After you finish treatment, you'll have follow-up check-ups every 3 months for two years to monitor your health.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of joining this study is getting access to a new treatment, capmatinib, which might help your specific cancer, especially if other treatments haven't worked or aren't suitable. However, there's no guarantee it will work for everyone, and like all medicines, capmatinib can cause side effects. These side effects can vary from person to person. You will be closely monitored for any reactions. It's very important to remember that participating is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Belfast City Hospital
    Verified postcode
    Belfast, United Kingdom· Recruiting
  • University Hospital Birmingham
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • Bristol Haematology and Oncology Centre
    Verified postcode
    Bristol, United Kingdom· Recruiting
  • Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom· Not yet recruiting
  • Velindre Cancer Centre
    Verified postcode
    Cardiff, United Kingdom· Recruiting
  • Western General Hospital
    Verified postcode
    Edinburgh, United Kingdom· Recruiting
  • The Beatson Hospital
    Verified postcode
    Glasgow, United Kingdom· Recruiting
  • Leicester Royal Infirmary
    Verified postcode
    Leicester, United Kingdom· Recruiting
  • University College London Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • Guy's Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • The Christie Hospital
    Verified postcode
    Manchester, United Kingdom· Recruiting
  • Clatterbridge Cancer Centre
    Verified postcode
    Metropolitan Borough of Wirral, United Kingdom· Recruiting

Common questions

What is 'MET dysregulation'?

It means there's a specific genetic change or fault in your cancer involving the MET gene, which the drug capmatinib is designed to target.

Is capmatinib a new drug?

It's already approved and used for certain lung cancers, but this study is testing if it can help people with other types of cancer.

How long will the treatment last?

You'll take capmatinib as long as it's helping you and you're not experiencing difficult side effects.

Will I have to pay for the drug?

No, all study-related treatments and tests are provided free of charge if you join the trial.

What happens if the drug doesn't work for me?

Your medical team will discuss other treatment options with you, and you can stop the study drug at any time.

How to find out more

Aida Sarmiento Castro

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

Interested in taking part?

Register your interest

Share your details and the research team for "DETERMINE Trial Treatment Arm 06: Capmatinib in Adult Patien…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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