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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study of safety and efficacy of novel targeted therapy combinations in adult patients with advanced or metastatic colorectal cancer.

This research study is focused on finding new treatments for a type of bowel (colorectal) cancer that has spread to other parts of the body (advanced or metastatic). Specifically, it's for people whose cancer has a particular genetic change known as BRAF V600. The study is in its early stages (Phase 1), meaning it's primarily designed to check the safety of new combinations of targeted therapies. Targeted therapies are medicines that specifically attack cancer cells while trying to minimise harm to healthy cells. By taking part, you would help doctors understand if these new combinations are safe and if they could be effective in shrinking or controlling this type of cancer. This research is vital for developing better treatment options in the future.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Novartis Pharma AG
Enrolment target
35
Start
10 Jun 2024

What is this study about?

This study is all about finding new and improved treatments for people with a type of bowel cancer that has spread to other parts of the body. When cancer spreads, doctors call it 'advanced' or 'metastatic'. This particular study focuses on people whose bowel cancer has a specific change in its genes, known as 'BRAF V600'. This gene change can make the cancer grow and spread, and it sometimes means that standard treatments might not work as well.

The researchers are testing combinations of new medicines called 'targeted therapies'. Unlike traditional chemotherapy which can affect many cells, targeted therapies are designed to specifically attack cancer cells that have certain characteristics, like the BRAF V600 gene change. The aim is to slow down or stop the cancer from growing, while hopefully causing fewer side effects on healthy cells.

This is an early-stage study, often called 'Phase 1'. This means the main goal is to carefully check how safe these new medicine combinations are and to find the right dose. The study will also look for early signs of whether these treatments are helping to control the cancer. Your participation would be really important in helping doctors understand if these new approaches could lead to better treatments for future patients.

Key takeaways

  • This study is for adults with advanced bowel cancer that has spread.
  • Your cancer must have a specific BRAF V600 gene change.
  • It's testing new combinations of 'targeted' medicines.
  • The main aim is to check the safety and find the right dose of these new treatments.
  • Participation involves regular hospital visits for treatments and health checks.
  • You can stop taking part at any time without affecting your care.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older.

The study is specifically for people who have advanced or metastatic bowel cancer. This means your cancer has spread from where it started. Critically, your cancer must also have a specific genetic change called BRAF V600. Your doctors would have tested your cancer cells for this.

There will be other detailed health checks to make sure the study treatment is safe for you. This might include checking your general health, organ function, and current medications. Your doctor will discuss all these criteria with you to see if this study is a good fit.

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. Has your bowel cancer spread to other parts of your body?
  3. Has your doctor told you that your cancer has the 'BRAF V600' gene change?
  4. Are you generally well enough to take part in a clinical study?
  5. Are you willing and able to attend regular hospital appointments?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given new combinations of medicines. You would have regular visits to the hospital or clinic for these medicines, and to have various tests. These tests might include blood tests, scans (like CT scans or MRI scans) to check how the cancer is responding, and general health checks. The purpose of these visits is to monitor your health and to see how the treatment is affecting you and your cancer. The length of time you would be in the study can vary. You would continue treatment as long as it is helping you and you are not experiencing severe side effects. After stopping treatment, there would likely be follow-up appointments to keep an eye on your health.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment that could help control your cancer, possibly better than existing options. However, as these are new medicines, there's always a risk of unexpected side effects, which could be mild or serious. The study team will monitor you very closely for any side effects and will explain all known risks before you decide to join. Remember, taking part in a study is completely voluntary, and you can withdraw at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain

Common questions

What does 'advanced or metastatic' mean?

It means the cancer has spread from where it started to other parts of your body.

What is 'BRAF V600 colorectal cancer'?

This is bowel cancer that has a specific genetic change, or 'mutation', called BRAF V600, identified through a special test.

What are 'targeted therapies'?

These are medicines designed to specifically attack cancer cells that have certain weaknesses, like the BRAF V600 change, while trying to protect healthy cells.

Will this study cure my cancer?

This is an early-stage study primarily focused on checking safety and finding the right dose. While we hope for positive effects, it's not guaranteed to cure cancer.

Will I get a placebo (dummy drug) in this study?

No, in this type of study, all participants receive the active study medicine combinations.

How to find out more

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

Discussion

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