RecruitingPHASE4INTERVENTIONAL

Dabrafenib and/or Trametinib Rollover Study

This study is for patients who are currently receiving treatment with the medicines dabrafenib and/or trametinib as part of an existing clinical trial sponsored by Novartis or GSK. The main aim is to give these patients continued access to their treatment if their doctor believes it is still benefiting them and if they have met the main goals of the original study. It's open to adults aged 18 to 100 with various cancers, such as melanoma, a type of lung cancer, some solid tumours, rare cancers, and high-grade glioma. This is not a new treatment trial, but rather a way for patients to keep receiving a treatment that is already helping them.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Novartis Pharmaceuticals

Enrolment target

100

Start

28 Dec 2017

Estimated completion

28 Dec 2032

Melanoma Non Small Cell Lung Cancer Solid Tumor Rare Cancers High Grade Glioma

What is this study about?

This study is designed for individuals who are already taking specific cancer medications called dabrafenib and/or trametinib within another research study. Think of it as a way for patients to 'roll over' into a new study to keep getting their current treatment. The original study might be ending, but if your doctor thinks these medicines are still helping you, this new study allows you to continue receiving them.

The main goal is to ensure continuous care for patients who are responding well to these treatments. Dabrafenib and trametinib are used for various types of cancer, including melanoma (a serious skin cancer), a type of lung cancer called non-small cell lung cancer, other solid tumours, some rare cancers, and a brain tumour called high-grade glioma.

It's important to understand that this study isn't testing new medicines or trying out a new way to use these drugs. Instead, it's a practical measure to let patients who are benefiting from dabrafenib and/or trametinib continue their treatment without interruption, under close medical supervision.

Key takeaways

This study is for continuing existing cancer treatment.
It's for specific cancers like melanoma and lung cancer.
You must already be in another clinical trial with these drugs.
Your doctor must believe the treatment is still helping you.
Regular health checks will continue as part of the study.
You can leave the study at any time.

Who may be eligible?

You might be able to join this study if you are currently taking dabrafenib and/or trametinib as part of another study sponsored by Novartis or GSK. Your doctor must also believe that you are still benefiting from the treatment you are receiving.

However, you will not be able to join if you stopped your study treatment permanently in the original study. Also, if the treatment you're receiving is already available and paid for by the NHS in the UK, you won't be able to join. Finally, if you currently have health problems that caused your dabrafenib and/or trametinib treatment to be stopped temporarily in your previous study, you would not be eligible until those issues are resolved.

This study is for adults generally between 18 and 100 years old, and it's open to both men and women.

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.

Are you currently taking dabrafenib and/or trametinib in another study?
Does your doctor think the treatment is still helping you?
Has the treatment not caused you to stop permanently in your old study?
Is this specific treatment not yet routinely available and paid for by the NHS for your condition?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue to receive your current treatment with dabrafenib and/or trametinib, exactly as you have been. You won't start any new medicines or have a new treatment plan from what you're already used to. You will have regular appointments with your study doctor and nurses, similar to how your current study works. These visits will involve check-ups to monitor your health, how you're responding to the treatment, and to check for any side effects.

The specific length of your participation will depend on how long your doctor believes the treatment continues to benefit you. You will be closely monitored throughout, ensuring your safety and well-being. The study will continue as long as you are benefiting and feel well enough, or until the treatment becomes commercially available for your condition in the UK.

Potential risks and benefits

The main benefit of joining this study is the ability to continue receiving a treatment that your doctor believes is helping you. This means you won’t have to stop a beneficial treatment just because your previous study has finished. As you are already on these medications, you will be familiar with the potential side effects. The risks involved are generally the known side effects of dabrafenib and/or trametinib, which your medical team will continue to monitor closely. Your safety is paramount, and your doctors will ensure that staying on the treatment remains the best option for you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (29)

Honor Health Research Institute
Verified postcode
Scottsdale, United States· Active not recruiting
Honor Health Research Institute
Verified postcode
Scottsdale, United States· Recruiting
National Institute Of Health
Verified postcode
Bethesda, United States· Active not recruiting
James Cancer Hospital and Solove Research Institute Ohio State
Verified postcode
Columbus, United States· Completed
Mary Crowley Cancer Research
Verified postcode
Dallas, United States· Completed
Novartis Investigative Site
City only
Caba, Argentina· Completed
Novartis Investigative Site
Verified postcode
Innsbruck, Austria· Active not recruiting
Novartis Investigative Site
Verified postcode
Beijing, China· Completed
Novartis Investigative Site
Verified postcode
Copenhagen, Denmark· Active not recruiting
Novartis Investigative Site
Verified postcode
Lyon, France· Active not recruiting
Novartis Investigative Site
Verified postcode
Nantes, France· Active not recruiting
Novartis Investigative Site
Verified postcode
Paris, France· Completed

Common questions

What is dabrafenib and trametinib?

These are specific medicines used to treat certain types of cancer, particularly those with specific genetic changes.

Why is this study happening?

This study allows patients already benefiting from dabrafenib and/or trametinib in another study to continue receiving their treatment.

Am I taking new medication in this study?

No, you will continue to take the same medication (dabrafenib and/or trametinib) you are currently receiving.

How long will I be on the study medication?

You will continue as long as your doctor believes the treatment is helping you and you meet the study requirements.

Can I stop the study at any time?

Yes, you have the right to withdraw from the study at any point, and it will not affect your medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

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