Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
This study is looking for people in the UK who have had surgery for a type of pancreatic cancer called pancreatic ductal adenocarcinoma (PDAC). The main aim is to understand if a new medicine, daraxonrasib, can help prevent the cancer from returning after surgery and chemotherapy. We will compare this new drug to the usual approach of simply monitoring patients after their initial treatment. We hope to find out if daraxonrasib is safe and effective in improving how long people stay cancer-free. This is a large study involving many people to get clear answers about this potential new treatment.
At a glance
What is this study about?
This study is aimed at people in the UK who have been diagnosed with pancreatic ductal adenocarcinoma (PDAC), a common type of pancreatic cancer. You might be interested if you've already had an operation to remove the cancer completely.
The main goal of this research is to see if a new medication called daraxonrasib can help stop the cancer from coming back after surgery and chemotherapy. Currently, after these treatments, doctors usually just monitor patients. This study will compare daraxonrasib to this standard monitoring approach to find out if the new drug can keep people cancer-free for longer. We also want to understand if it's safe to use.
By taking part, you could help doctors learn more about treating pancreatic cancer and potentially improve future care for others. It’s an important step in finding better ways to manage this condition.
Key takeaways
- This study tests a new drug for pancreatic cancer after surgery.
- It aims to prevent the cancer from returning.
- It compares the new drug to standard monitoring.
- You must have completed chemotherapy recently.
- You need to be generally healthy and able to take oral medicine.
- Participation could help improve future treatments for pancreatic cancer.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old, and have had surgery to completely remove your pancreatic cancer (PDAC). You must not show any signs of the cancer having returned or spread to other parts of your body. Also, you should have already completed a course of chemotherapy, either before or after your surgery, and finished this treatment within the last 12 weeks.
Your body should be generally healthy enough to take part, meaning your blood, liver, and kidney functions are working well. You also need to be able to take medicines by mouth. The doctors will check your cancer's specific genetic information to see if it has a certain change called a 'RAS mutation', which is important for this study.
You cannot join if you've had a similar type of targeted RAS treatment before, or if you have other health issues that might make it difficult to take the study medicine or attend appointments. If you've had major surgery recently (in the last 28 days), you'll need to wait.
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.
- I am at least 18 years old.
- I have had surgery to remove my pancreatic cancer (PDAC) and it has not returned.
- I have finished chemotherapy (before or after surgery) within the last 12 weeks.
- I am generally healthy, and my body organs are working well.
- I am able to take medicines by mouth.
- I have not had similar targeted RAS-blocking drugs before.
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of two groups. One group will receive the new medicine, daraxonrasib, which you will take by mouth. The other group will be monitored in the usual way, without receiving this new drug. Neither you nor your doctor will get to choose which group you are in, and it's also 'open-label', meaning both you and your doctor will know which treatment you are receiving.
Throughout the study, you will have regular visits with the study team. These visits will involve check-ups, blood tests, and scans to monitor your health and see how you are responding. The doctors will closely watch for any signs of the cancer returning or any side effects from the medication. The total duration of your participation will depend on how you respond to treatment and other factors, and the study team will explain this in detail.
Potential risks and benefits
Locations (17)
- University of California, Los AngelesVerified postcodeLos Angeles, United States· Recruiting
- University of California, San FranciscoVerified postcodeSan Francisco, United States· Not yet recruiting
- Hartford HealthcareVerified postcodeHartford, United States· Recruiting
- Community Health NetworkVerified postcodeIndianapolis, United States· Recruiting
- University of Kansas Medical Center Research Institute, Inc.Verified postcodeLawrence, United States· Recruiting
- Sidney Kimmel Comprehensive Cancer Center, Johns HopkinsVerified postcodeBaltimore, United States· Recruiting
- Saint Luke's Cancer InstituteVerified postcodeKansas City, United States· Recruiting
- Columbia University Medical CenterVerified postcodeNew York, United States· Recruiting
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Recruiting
- Taylor Cancer Research CenterVerified postcodeMaumee, United States· Recruiting
- Avera Cancer InstituteVerified postcodeSioux Falls, United States· Recruiting
- University of Utah, Huntsman Cancer InstituteVerified postcodeSalt Lake City, United States· Recruiting
Common questions
What is PDAC?
PDAC stands for Pancreatic Ductal Adenocarcinoma, which is the most common type of pancreatic cancer.
Why is this study important?
It's important because it aims to find out if a new drug can help stop pancreatic cancer from coming back after surgery and chemotherapy, potentially improving future treatments.
Will I know if I'm getting the new drug?
Yes, in this study, both you and your doctor will know whether you are receiving daraxonrasib or are in the observation group.
What happens if the cancer comes back?
The study team will closely monitor you. If the cancer shows signs of returning, your study doctor will discuss the next steps for your care.
Do I have to pay to be in the study?
No, all study-related treatments, tests, and visits are provided at no cost to you.
How to find out more
Revolution Medicines Study Director
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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