RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2‑Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients with Resected Pancreatic Ductal Adenocarcinoma (PDAC)
This research study, called RASolute 304, is testing a new medication called daraxonrasib for adults who have had surgery for pancreatic cancer (specifically, pancreatic ductal adenocarcinoma, or PDAC). After surgery, some people have chemotherapy to try and stop the cancer returning; this study is looking at whether adding daraxonrasib after this standard treatment is more effective than just ongoing check-ups. The main goal is to find out if daraxonrasib can help keep the cancer from coming back for longer. Researchers will also look at how long people live, how safe the drug is, and how the body handles it. It's a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available.
At a glance
What is this study about?
This study, known as RASolute 304, is for people who have been diagnosed with a type of pancreatic cancer called pancreatic ductal adenocarcinoma (PDAC). This is the most common kind of pancreatic cancer. You can take part if you've recently had surgery to remove the cancer and completed any follow-up chemotherapy treatments that your doctor recommended. The study wants to see if a new drug, called daraxonrasib, can help prevent the cancer from returning after standard treatments. Currently, after surgery and chemotherapy, patients usually have regular check-ups to monitor their health. This study compares giving daraxonrasib to just continuing with these regular check-ups.
The main aim of this research is to measure how long people stay free from cancer coming back. This is often called 'disease-free survival'. Researchers will carefully monitor participants to see if the cancer comes back and, if so, when. They will also look at other important things, like how long people live overall, how safe daraxonrasib is, and if it causes any side effects. By comparing daraxonrasib to standard care, the study hopes to find out if this new drug could offer a better way to prevent cancer recurrence for people with PDAC.
This is a 'Phase 3' study, which means it's a large, important trial that helps confirm whether a new treatment is effective and safe enough to be made available to more people. This phase usually involves a larger number of patients and is compared against existing treatments or standard care. The results from studies like this are crucial for developing new cancer treatments.
Key takeaways
- Tests a new drug (daraxonrasib) for pancreatic cancer after surgery and chemotherapy.
- Aims to see if the drug stops the cancer from coming back for longer.
- Compares the new drug to standard follow-up care.
- Involves regular hospital visits, assessments, and potentially taking medication.
- It's a major 'Phase 3' study to confirm effectiveness and safety.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women can take part.
You would be considered for this study if you have been diagnosed with pancreatic ductal adenocarcinoma (PDAC), had surgery to remove the cancer, and have also completed any recommended chemotherapy treatments before or after your surgery.
There might be other specific health requirements or conditions that would determine if you can join, which your doctor would discuss with you in detail. It's important to talk to your healthcare team to understand if this study is suitable for your individual 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?
- Have you had surgery for pancreatic ductal adenocarcinoma (PDAC)?
- Have you completed any recommended chemotherapy treatments (before or after surgery)?
- Are you generally well enough to participate in a clinical study?
What does participation involve?
If you decide to take part in this study, you would either receive the new drug, daraxonrasib, or continue with your usual follow-up care (which means regular check-ups without the study drug). This will be decided by chance, like flipping a coin. You wouldn't get to choose which group you are in.
Taking part would involve regular visits to the hospital or clinic. These visits will include various assessments, such as physical examinations, blood tests, and scans (like CT or MRI scans) to check your health and see if the cancer has returned. If you are in the treatment group, you would be taking the daraxonrasib medication as instructed. The study team will explain how to take the medication and what to expect.
You would be followed closely for a period of time to track your health and any changes. The total duration of your participation, including follow-up, will be explained during your initial discussions with the study team.
Potential risks and benefits
Locations (4)
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedGermany
Common questions
What is pancreatic ductal adenocarcinoma (PDAC)?
It's the most common type of cancer that starts in the pancreas, an organ in your tummy that helps with digestion and making hormones.
What does 'adjuvant' treatment mean?
Adjuvant treatment is extra treatment given after the main treatment (like surgery) to try and reduce the chance of the cancer coming back.
Will I definitely get the new drug?
No. Participants are randomly assigned to either receive the new drug or continue with standard medical care. It's like flipping a coin, so you won't get to choose.
What is a 'Phase 3' study?
A Phase 3 study is a large study that compares a new treatment with existing treatments or standard care to see if it's better and safe enough to be used more widely.
What if I change my mind about participating?
You have the right to leave the study at any time, for any reason, without affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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