Active not recruitingPHASE3INTERVENTIONAL

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

This research study is for people in the UK who have pancreatic cancer that has spread to other parts of their body and has already been treated with chemotherapy at least once before. The main goal is to test a new medication, called RMC-6236, against the usual chemotherapy treatments. Doctors want to find out if RMC-6236 can help people live longer or stop their cancer from growing for a longer time, compared to standard care. Participants will be split into two groups by chance. One group will receive the new medicine, and the other will receive a standard chemotherapy treatment chosen by their doctor. The study will also look at any side effects and how the treatments affect people's quality of life. This is a crucial step in finding better ways to treat advanced pancreatic cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Revolution Medicines, Inc.

Enrolment target

500

Start

16 Oct 2024

Estimated completion

01 Dec 2027

Pancreatic Cancer PDAC PDAC - Pancreatic Ductal Adenocarcinoma

What is this study about?

Pancreatic cancer can be very challenging to treat, especially when it has spread (metastasised) to other parts of the body. For people living with this type of cancer, doctors are always searching for new and improved treatments. This particular research study is called a 'Phase 3' trial, which means it's a large and important step to see if a new treatment can become widely available.

The main idea behind this study is to test a new medicine called RMC-6236. This medicine works differently from traditional chemotherapy. Researchers believe it might target some of the specific changes that happen in cancer cells, particularly those related to a gene called RAS. By targeting these changes, they hope RMC-6236 will be more effective and potentially have different side effects than current treatments. The study aims to see if patients who receive RMC-6236 live longer or if their cancer takes longer to grow back, compared to receiving standard chemotherapy.

To make sure the results are fair and reliable, people taking part will be divided into two groups by chance. One group will get the new RMC-6236 medicine, and the other group will get one of the standard chemotherapy treatments that doctors currently use for this type of cancer. All participants will be closely monitored by a team of doctors and nurses throughout the study. This research is vital to understanding if RMC-6236 could offer a new and better option for people with advanced pancreatic cancer in the future.

Key takeaways

This study tests a new medicine for advanced pancreatic cancer that has spread.
It's for people who have already had chemotherapy for their cancer.
The new medicine (RMC-6236) is compared to standard chemotherapy.
Participation involves regular hospital visits, tests, and taking study medication.
The goal is to find out if RMC-6236 can help people live longer or stop cancer growth for longer.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have pancreatic cancer that has spread. You must have already had at least one course of chemotherapy for your cancer. Your doctors will also need to confirm that your body is generally strong enough to take part in the study, for example, your blood, liver, and kidney functions need to be quite healthy.

An important part of this study is understanding specific changes in your cancer cells. Therefore, your doctors will need to know if your cancer has a particular change in a gene called RAS. You also need to be able to swallow pills, as the new study medicine is taken by mouth.

There are also some reasons why you might not be able to join. For instance, if you've had previous experimental treatments that directly targeted the RAS gene, or if your cancer has spread to your brain or spinal cord. Also, if you've had major surgery recently (within the last four weeks), or if there are other health conditions that would make it difficult for you to take the study medicine or attend all your appointments, you might not be suitable.

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 cancer that has spread?
Have you already had at least one round of chemotherapy for your cancer?
Are you generally well enough to take part and attend appointments?
Are you able to swallow tablets?
Has your doctor checked if your cancer has a specific 'RAS gene mutation'?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two groups by chance – like flipping a coin. One group will receive the new medicine, RMC-6236, which is taken as tablets. The other group will receive standard chemotherapy, chosen by your doctor, which might be given through a drip.

Throughout the study, you will have regular visits with the study team. These visits will involve blood tests, physical examinations, and scans (like CT scans) to check how the treatment is working and monitor for any side effects. You'll also be asked questions about how you're feeling. The study will continue for as long as the treatment is helping you and you are tolerating it well. After you stop treatment, you will continue to have follow-up appointments to track your health and survival.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A possible benefit of joining this study is that you might receive a new treatment that could be more effective than standard options, or have different, possibly more manageable, side effects. However, there's no guarantee the new medicine will work for you, or that it will be better than standard treatment. As with all medicines, RMC-6236 may cause side effects, some of which could be serious. The study team will closely monitor you for any side effects and will explain all known risks before you make a decision. Remember, your participation is completely voluntary, and you can change your mind and withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (60)

Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States
Mayo Clinic Cancer Center - Phoenix
Verified postcode
Phoenix, United States
City of Hope-Duarte
Verified postcode
Duarte, United States
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States
UCLA
Verified postcode
Los Angeles, United States
UC San Diego Health Moores Cancer Center
Verified postcode
San Diego, United States
Mission Hall UCSF
Verified postcode
San Francisco, United States
Rocky Mountain Cancer
Verified postcode
Aurora, United States
Mayo Clinic Cancer Center - Florida
Verified postcode
Jacksonville, United States
University of Miami Sylvester Comprehensive Cancer Center
Verified postcode
Miami, United States
Cancer Care Centers of Brevard Inc
Verified postcode
Palm Bay, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States

Common questions

What is pancreatic cancer?

Pancreatic cancer starts in the pancreas, an organ in your tummy that helps with digestion and making hormones like insulin. When it spreads, it's called 'metastatic'.

What is RMC-6236?

RMC-6236 is a new experimental medicine being tested in this study. It's designed to target specific changes in cancer cells that are linked to a gene called RAS.

Why is this a 'Phase 3' study?

Phase 3 means this is a large study to see if the new treatment is better or safer than current standard treatments. If successful, it could mean the medicine becomes available to more patients.

Will I definitely get the new medicine?

No, you will be randomly assigned to one of two groups. One group gets the new medicine (RMC-6236), and the other gets standard chemotherapy. You won't know which one you're getting until you start.

What is a 'RAS gene mutation'?

A RAS gene mutation is a specific change in the DNA of cancer cells that can make them grow out of control. This study is looking at treatments that might target these specific changes.