(20289) A Phase 2 Basket Study of the Oral TRK Inhibitor larotrectinib in Subjects with NTRK Fusion-Positive Tumors
This research study, called a Phase 2 trial, is looking at a new oral medicine named larotrectinib. It's for adult patients whose solid tumours have a particular genetic alteration known as an 'NTRK fusion'. Researchers want to find out how effective larotrectinib is at shrinking these tumours, whether completely or partially. They will carefully monitor how long the positive effects last and how patients' quality of life is affected. Safety is also a key focus, with doctors watching for any side effects. This study aims to provide important information about this new treatment option for people with NTRK fusion-positive cancers.
At a glance
What is this study about?
This study is a type of clinical trial called a 'Phase 2 basket study'. In simple terms, this means we're looking at a new medicine, larotrectinib, for people aged 18 and over who have solid tumours. What makes this study special is that it's for tumours that all share a particular genetic change, called an 'NTRK fusion'. Think of it like a specific key (the NTRK fusion) that unlocks a certain door (the cancer's growth). Larotrectinib is designed to block that key, potentially stopping the cancer from growing.
The main goal of this study is to see how much the medicine can shrink the tumours, or even make them disappear completely. Doctors will use special scans to measure this carefully. They'll also be looking at how long these positive effects last and how long patients live without their cancer growing. Because treatments can affect people differently, they'll also compare these results with what happened before the patient started larotrectinib.
Ultimately, this research helps doctors understand if larotrectinib is a good and safe treatment option for people with NTRK fusion-positive solid tumours. Learning more about new medicines helps improve future care for patients with cancer.
Key takeaways
- This study is for adults with solid tumours that have a specific 'NTRK fusion' genetic change.
- The medicine being tested is an oral drug called larotrectinib.
- The main aim is to see how well the medicine shrinks tumours and how safe it is.
- Regular health checks, blood tests, and scans will be part of the study.
- It's important to discuss all aspects with your doctor before deciding to participate.
Who may be eligible?
This study is specifically looking for adult patients, meaning you must be 18 years old or older. Both men and women are welcome to take part in this research.
The most important requirement for this study is that your cancer must have a specific genetic change. This change is called an 'NTRK fusion'. Your doctor would typically test for this in your tumour.
There might be other health requirements or previous treatments you've had that could affect your ability to join, but your doctor will go through all of these details with you to make sure the study is right for your particular situation.
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 18 years old or older?
- Has your doctor told you that your tumour has an 'NTRK fusion'?
- Are you able to take medicine by mouth (pills)?
- Are you willing and able to attend regular hospital visits for tests and monitoring?
What does participation involve?
If you decide to take part, you would be taking the study medicine, larotrectinib, as an oral medication (a pill). You'd have regular appointments with the study team. During these visits, doctors and nurses would do physical exams, take blood and other samples, and ask you about how you're feeling and any side effects you might be having. You would also have scans (like CT or MRI) to see how your tumour is responding to the treatment.
The study team will carefully monitor your health throughout. The total duration of your participation could vary, as it depends on how you respond to the treatment and your overall health. You would continue to be monitored for a period even after stopping the study medicine.
Potential risks and benefits
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Common questions
What is an 'NTRK fusion'?
It's a specific genetic fault in some cancer cells that helps the cancer grow. This study drug is designed to target it.
What does a 'Phase 2 study' mean?
It means the drug has been tested for safety, and now we're looking to see how well it works and if it has useful effects on the cancer.
Will I get the actual study drug, or a placebo?
In this specific study, all participants will receive the active study drug, larotrectinib. There is no placebo group.
How will doctors know if the medicine is working?
They will use regular scans and tests to measure any changes in your tumour size and assess your overall health.
What if I experience side effects?
The study team will monitor you closely for any side effects and will provide support and advice on how to manage them.
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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