Active not recruitingPHASE2INTERVENTIONAL

Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone

This study provides continued treatment for patients who are already receiving capmatinib, or a combination of capmatinib with other treatments, for advanced solid tumours in a previous Novartis-sponsored study. The main goal is to check the long-term safety of these treatments. It also ensures that patients who are benefiting from their current treatment can keep receiving it. This is particularly useful if the treatment isn't yet widely available. Patients will continue to receive their medication and have regular check-ups to monitor their health until their doctor decides it's no longer benefiting them or if other reasons for stopping arise.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

Start

23 Aug 2017

Estimated completion

30 Jul 2027

Advanced Solid Tumors Which Are cMET-dependent

What is this study about?

This study is designed for individuals who are currently taking part in another Novartis-sponsored medical trial for advanced solid tumours. If you're on a treatment that includes capmatinib, either on its own or with other medicines, and your doctor thinks it's helping you, this study allows you to keep receiving that treatment for a longer period. It's essentially a way to continue care and monitor your health over time, especially if the treatment isn't something you can easily get outside of a clinical trial yet.

The main aim of continuing this treatment is to closely watch its long-term safety. Doctors want to understand how your body reacts to the medication over an extended period. This kind of study is important because it helps ensure that patients who are benefiting from an important treatment can continue to receive it, while also gathering valuable information about its long-term effects.

You'll continue to receive your study medication and have regular check-ups. These appointments are important for monitoring your progress and making sure the treatment continues to be safe and effective for you. The study aims to provide ongoing support and treatment as long as your doctor believes it's helping you and you're not experiencing any severe side effects.

Key takeaways

This study offers continued treatment if you're already in a Novartis cancer trial and benefiting from capmatinib.
The main goal is to understand the long-term safety of these treatments.
You'll have regular check-ups to monitor your health and treatment effects.
Participation ensures ongoing access to your current treatment if it's not widely available yet.
You can leave the study at any time.
It helps gather vital information about how these medicines work over time.

Who may be eligible?

To be able to join this study, you must already be receiving treatment with capmatinib (either alone or with other medicines) as part of another Novartis study, and your doctor must believe that this treatment is currently benefiting you. Even if you stopped capmatinib but are still on the combination treatment, you might be eligible if that combination isn't easily available outside of a study.

It's also important that you are able and willing to attend all scheduled appointments, follow the treatment plan, and complete any other study procedures. You'll need to provide written consent, which means you agree to take part after fully understanding what it involves.

However, you won't be able to join if you're currently experiencing side effects from your previous study treatment that haven't cleared up. If you're pregnant or breastfeeding, this study is also not suitable. Women who could become pregnant must use highly effective contraception during the study and for a period afterwards.

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.

Am I already taking capmatinib (or a capmatinib combination) in another Novartis study?
Does my current doctor think this treatment is helping me?
Can I attend regular appointments and follow the study instructions?
Am I free from any unresolved severe side effects from my previous treatment?
Am I not pregnant or breastfeeding?
If I could become pregnant, am I willing to use effective contraception?

Answer every question to see your result.

What does participation involve?

If you join this study, there won't be a waiting period; you'll start your treatment in this study as soon as you're eligible and have given your consent. You'll need to attend your study centre regularly to pick up your medication and for safety checks. This means doctors will monitor your health to make sure the treatment continues to be safe for you. If there's a public health emergency, like an epidemic, arrangements might be made for you to continue your care in different ways, outside of the usual on-site visits.

You'll continue receiving treatment for as long as your doctor believes it's helping you, or until you experience side effects that are too difficult to manage. Treatment would also stop if your cancer gets worse, if you decide you no longer want to participate, or if the treatment becomes widely available outside of a study. The total duration of your participation will depend on how you respond to the treatment and your individual circumstances, as there isn't a fixed end date for all participants.

Potential risks and benefits

The main potential benefit of joining this study is the continued access to a treatment that your doctor believes is helping you, especially if it's not yet available outside of a research setting. This ensures ongoing care and support for your condition. As with any medical treatment, there are potential risks, which include experiencing side effects from the medication. Your doctors will carefully monitor you for any side effects and manage them as best they can. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (15)

Massachusetts General Hospital
Verified postcode
Boston, United States
Novartis Investigative Site
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Leuven, Belgium
Novartis Investigative Site
Verified postcode
Edmonton, Canada
Novartis Investigative Site
Verified postcode
Shanghai, China
Novartis Investigative Site
Verified postcode
Kunming, China
Novartis Investigative Site
Verified postcode
Copenhagen, Denmark
Novartis Investigative Site
Verified postcode
Dijon, France
Novartis Investigative Site
Verified postcode
Cologne, Germany
Novartis Investigative Site
Verified postcode
Hanover, Germany
Novartis Investigative Site
Verified postcode
Perugia, Italy
Novartis Investigative Site
Verified postcode
Milan, Italy
Novartis Investigative Site
Verified postcode
Singapore, Singapore

Common questions

What is capmatinib?

Capmatinib is a medicine that is being studied for treating certain types of advanced solid tumours. It targets specific changes in cancer cells.

Why is this study only for people already in another trial?

This study is designed to allow those already receiving treatment in a previous Novartis trial to continue their care, mainly to check the long-term safety and effects of the treatment they are already benefiting from.

What kind of check-ups will I have?

You'll have regular appointments at the study centre for health checks. These are to monitor how you're responding to the treatment and to look for any side effects.

Can I stop the study at any time?

Yes, you have the right to stop participating in the study at any point, and your decision will not affect your future medical care.

What happens if I get pregnant while on the study?

If you are a woman who could become pregnant, you must use effective contraception during the study. If you were to become pregnant, you would likely need to stop the study treatment.