A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma
This research study is investigating a new treatment, Ampligen, for a type of pancreatic cancer that has grown into nearby tissues but hasn't spread far. This specific type of cancer is called 'locally advanced pancreatic adenocarcinoma.' People in the study will have already received a chemotherapy treatment called FOLFIRINOX. The main goal is to find out if Ampligen can extend the time before the cancer starts to grow again or gets worse. Researchers will also look at how safe Ampligen is. This is a Phase 2 study, which means it's an earlier stage of research designed to get a better understanding of the treatment before larger studies are done. Participants will be compared to a group who do not receive Ampligen.
At a glance
What is this study about?
This study is for people like you or someone you know who has a type of pancreatic cancer called 'locally advanced pancreatic adenocarcinoma'. This means the cancer has grown into areas close to the pancreas but hasn't spread to distant parts of the body yet. The aim of this research is to see if a new medicine called Ampligen can help. You might have already had a strong chemotherapy treatment called FOLFIRINOX, and this study looks at what happens after that.
The main thing researchers want to find out is whether Ampligen can help stop your cancer from growing or getting worse for a longer time. This is often called 'Progression-Free Survival'. They will measure this by regularly checking your cancer to see if it has grown or if you remain stable. They also want to make sure Ampligen is safe to use and understand any side effects it might cause.
This is a Phase 2 study. This means it's still relatively early in the testing process for Ampligen. The information gathered from this study will help doctors decide if Ampligen is a promising treatment that should be tested in even larger studies in the future. By joining, you'd be helping scientists learn more about new ways to treat pancreatic cancer.
Key takeaways
- The study explores a new drug, Ampligen, for locally advanced pancreatic cancer.
- It aims to see if Ampligen can stop cancer growth for longer.
- Participants must be over 18 and have received prior FOLFIRINOX chemotherapy.
- This is a Phase 2 study, focusing on early effectiveness and safety.
- You might receive Ampligen or be in a non-treatment comparison group.
- Participation involves regular check-ups over several years.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old. There's no upper age limit, so people of many ages can take part. Both men and women are welcome to participate in this research.
Since this study is specifically for pancreatic cancer that has not spread far but has grown locally (locally advanced pancreatic adenocarcinoma), your medical history will be carefully reviewed to ensure you meet this diagnosis. You would also need to have already received a specific chemotherapy treatment called FOLFIRINOX.
There will be other detailed health checks and tests done by the study doctors to make sure this particular study and the medicines involved are suitable and safe for you. It's important that your overall health allows you to take part.
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?
- Have you been diagnosed with 'locally advanced pancreatic adenocarcinoma'?
- Have you already received FOLFIRINOX chemotherapy?
- Are you able to attend appointments for regular check-ups and tests?
- Are you willing for your health to be monitored over a period of time?
What does participation involve?
If you decide to take part, you'll be assigned to either receive Ampligen or be in a control group that doesn't receive this specific treatment after your FOLFIRINOX. The study will involve regular check-ups and assessments, which might include scans and blood tests, to monitor your health and the cancer. These visits will start from your second visit or when you begin treatment.
The research team will closely monitor how your cancer responds to treatment and any side effects you might experience. The aim is to follow participants until either their cancer starts to grow, they pass away, or the study reaches its planned end, which could be up to 42 months (about 3 and a half years). You'll have ongoing support and monitoring throughout this period.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is 'locally advanced pancreatic cancer'?
It means the cancer has grown into nearby tissues but hasn't spread to distant parts of your body.
What is Ampligen?
Ampligen is the name of the new medicine being tested in this study for pancreatic cancer.
What does 'Phase 2' mean?
It's an early stage of clinical research to see if a new medicine is safe and shows promise for treating a condition.
Will I definitely get Ampligen if I join?
No, you might be in a group that receives Ampligen or a group that doesn't, to allow for comparison.
How long will the study last?
Your participation could last up to 42 months, or until your cancer progresses or you decide to leave the study.
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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