Phase 1b study investigating the association of NP137 with mFOLFIRINOX in locally advanced pancreatic ductal adenocarcinoma LAP NET 1
This research study, called LAP NET 1, is testing a new medicine, NP137, given together with a standard chemotherapy treatment known as mFOLFIRINOX. It's for adult patients who have a type of pancreatic cancer called pancreatic ductal adenocarcinoma. This specific kind of cancer is 'locally advanced,' meaning it has grown outside the pancreas but hasn't spread to distant parts of the body. Unfortunately, due to its size or location, surgery isn't an option at this stage. The main goal of this early-stage study is to understand more about how NP137 and mFOLFIRINOX work when given together. The researchers want to find out if this combination is safe and if it helps patients. This is one of the first times this new medicine, NP137, has been tested in people, especially alongside chemotherapy for pancreatic cancer.
At a glance
What is this study about?
This study is about a type of cancer that starts in the pancreas, an organ in your tummy that helps with digestion. The specific name is pancreatic ductal adenocarcinoma. In this study, doctors are looking at a new medicine called NP137. They are giving it to patients alongside a standard chemotherapy called mFOLFIRINOX. Chemotherapy is a common and important treatment for many cancers, and mFOLFIRINOX is often used for pancreatic cancer.
This study is for adults whose pancreatic cancer is 'locally advanced.' This means the cancer has grown into nearby tissues but hasn't spread to other parts of the body, like the lungs or bones. Unfortunately, for these patients, surgery to remove the cancer isn't possible right away. The hope is that this new combination of treatments could help shrink the cancer or stop it from growing, potentially making surgery an option later on or improving comfort and quality of life.
This is an early-stage study, meaning it's one of the first times this new medicine, NP137, has been tested in people. The main purpose is to learn how safe the combination of NP137 and mFOLFIRINOX is, and if they work well together. The doctors will be carefully watching for any side effects and how the body handles the new medicine. Finding new and better ways to treat pancreatic cancer is very important, and studies like this help us learn more and develop new options for the future.
Key takeaways
- This study is testing a new medicine (NP137) with standard chemotherapy (mFOLFIRINOX) for pancreatic cancer.
- It's for adults with 'locally advanced' pancreatic cancer that can't be removed by surgery.
- The main goal is to check the safety and how well the new treatment combination works.
- Participation involves regular hospital visits for treatment, tests, and follow-up.
- You can stop participating in the study at any time without affecting your regular medical care.
Who may be eligible?
This study is looking for adult patients, meaning you need to be 18 years old or older to take part. Both men and women are welcome to participate. The most important thing is that you have a specific type of pancreatic cancer called pancreatic ductal adenocarcinoma.
Your cancer needs to be 'locally advanced.' This means it has grown beyond the pancreas into nearby areas, but it hasn't spread to distant parts of your body. Also, it must be the kind of cancer that doctors have decided cannot be removed by surgery at this point. The study team will check other health details to make sure it's safe for you to join.
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?
- Do you have pancreatic ductal adenocarcinoma?
- Has your doctor told you your cancer is 'locally advanced' (hasn't spread far)?
- Has your doctor said surgery isn't an option for your cancer right now?
- Are you well enough to undergo chemotherapy?
What does participation involve?
If you decide to take part in this study, you'll receive the new medicine NP137 along with the standard mFOLFIRINOX chemotherapy. This will involve regular visits to the hospital for your treatments. During these visits, you'll have various tests such as blood tests, scans (like CT scans), and physical exams. These tests help the doctors keep track of your health, check for any side effects, and see how the treatment is affecting your cancer.
The study will involve several cycles of treatment, and your doctors will tell you exactly how long each cycle lasts and how many you can expect. After your treatment period, there will be a follow-up phase where you'll have appointments to see how you're doing in the longer term. The total time you'd be involved in the study, from your first dose to the final follow-up, will be explained by the study team.
Potential risks and benefits
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Common questions
What is pancreatic ductal adenocarcinoma?
It's the most common type of cancer that starts in the pancreas, an organ that helps with digestion and making hormones.
What does 'locally advanced' mean?
It means the cancer has grown outside the pancreas into nearby tissues, but it hasn't spread to distant parts of your body.
What is mFOLFIRINOX?
It's a combination of several chemotherapy drugs often used to treat pancreatic cancer.
Why is a 'Phase 1b' study mentioned?
This means it's an early-stage study in humans. The main goal is to check the safety of the new medicine and find the best dose to use.
Will I definitely get the new medicine?
Yes, in this particular study, all participants will receive the new medicine NP137 along with the standard chemotherapy.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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