All studies
RecruitingPHASE3INTERVENTIONAL

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

This clinical trial is testing a new treatment called daraxonrasib for people with advanced pancreatic cancer that has spread to other parts of the body. It's designed for patients who haven't had previous treatment for their advanced cancer. Researchers want to see if daraxonrasib, either on its own or given alongside standard chemotherapy (gemcitabine and nab-paclitaxel), is better at controlling the cancer and helping people live longer, compared to standard chemotherapy alone. Patients will be put into one of three groups by chance: one group will receive daraxonrasib, another will receive daraxonrasib plus standard chemotherapy, and the third group will receive standard chemotherapy only. The study is also looking at how safe these treatments are.

At a glance

What is this study about?

When someone is diagnosed with pancreatic cancer that has spread, doctors often recommend chemotherapy as a first step. This study is testing a new medicine called daraxonrasib. This drug works by targeting specific changes in cancer cells that can help them grow. Researchers want to find out if this new drug can offer a better way to treat advanced pancreatic cancer than what is currently available.

The trial will compare daraxonrasib in two ways: first, on its own, and second, in combination with a standard chemotherapy treatment that doctors already use. This standard treatment involves two drugs, gemcitabine and nab-paclitaxel. All three options will be compared to see if daraxonrasib, either alone or with chemotherapy, can help slow down the cancer's growth for longer and potentially help people live longer.

Taking part in a study like this means you would be helping doctors learn more about the best ways to treat pancreatic cancer. While there's no guarantee of benefit, your involvement could lead to improved treatments for future patients.

Key takeaways

  • This study is for people with advanced pancreatic cancer that has spread.
  • It tests a new drug, daraxonrasib, alone or with standard chemotherapy.
  • It's the first treatment for advanced cancer, meaning you haven't had other treatments for the spread.
  • You'll be randomly assigned to one of three treatment groups.
  • The main goals are to see if the new treatments can control cancer for longer and improve how long people live.
  • Participation involves regular hospital visits, treatments, and checks.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have pancreatic cancer that has spread to other parts of your body. Your doctor would need to have confirmed this diagnosis recently, within the last six weeks before you joined the study. It's also important that your body is generally strong enough for treatment; doctors use a simple score (called ECOG 0 or 1) to check this, meaning you are able to do most of your daily activities.

You would also need to have not received any previous cancer treatment for your advanced pancreatic cancer, and your doctors would need to check that your important organs, like your liver, kidneys, and bone marrow, are working well enough. You'd also need to be able to swallow medicines if they are given as tablets.

Some things might mean you can't join the study. For example, if you've had major surgery very recently (in the last 28 days), or if your cancer has spread to your brain and isn't under control. Also, if there are other health conditions that would make it difficult for you to take the study drugs or follow the study plan, you might not be able to participate. Your doctor will discuss all of these points with you carefully.

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.

  1. Are you at least 18 years old?
  2. Do you have pancreatic cancer that has spread to other parts of your body?
  3. Have you *not* had previous treatment for your advanced pancreatic cancer?
  4. Are you generally able to do most of your daily activities?
  5. Can you swallow tablets if needed?
  6. Have you not had major surgery in the last 4 weeks?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a number of checks to make sure the study is right for you. If you qualify, you will then be randomly assigned, like flipping a coin, to one of three treatment groups. This means you won't choose which treatment you get. You will either receive the new drug daraxonrasib by itself, daraxonrasib plus standard chemotherapy, or just the standard chemotherapy (gemcitabine and nab-paclitaxel).

Throughout the study, you will have regular visits to the hospital for your treatments, blood tests, scans (like CT scans) to check how the cancer is responding, and to discuss any side effects you might be experiencing. The study drugs may be given as tablets or through a drip (infusion). You'll be closely monitored by the study team. The total length of your participation will depend on how you respond to the treatment and whether you have any side effects, but it will continue as long as the treatment is helping you and is safe to take, with regular follow-up checks after treatment finishes.

Potential risks and benefits

Participating in this study means you might receive a new treatment that could potentially be more effective at controlling your cancer and helping you live longer than current options. However, new treatments also come with unknown risks and side effects, which could be different or more severe than those of standard treatments. You might also experience side effects from the standard chemotherapy. There's no guarantee that the treatment will work for you, and it's possible you might not benefit. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

  • Honor Health Research Institute
    Verified postcode
    Scottsdale, United States· Recruiting
  • University of California San Francisco
    Verified postcode
    San Francisco, United States· Recruiting
  • H Lee Moffitt Cancer Center and Research Institute
    Verified postcode
    Tampa, United States· Recruiting
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    Verified postcode
    Baltimore, United States· Recruiting
  • Dana-Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • Comprehensive Cancer Centers of Nevada
    Verified postcode
    Henderson, United States· Active not recruiting
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • University of Cincinnati Cancer Center
    Verified postcode
    Cincinnati, United States· Recruiting
  • Taylor Cancer Research Center
    Verified postcode
    Maumee, United States· Active not recruiting
  • SCRI Oncology Partners
    Verified postcode
    Nashville, United States· Recruiting
  • SCRI - Texas Oncology Dallas
    Verified postcode
    Dallas, United States· Recruiting
  • MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting

Common questions

What is 'metastatic pancreatic adenocarcinoma'?

This is a type of pancreatic cancer that has spread from the pancreas to other parts of the body.

What is 'first-line treatment'?

This means it's the first treatment given for your advanced cancer, before any other treatments for the spread of the cancer.

What does 'randomized' mean?

It means you'll be put into one of the treatment groups by chance, like drawing lots, so neither you nor your doctor can choose which one you get.

Is daraxonrasib already approved?

No, daraxonrasib is an 'investigational' drug, which means it's still being studied and is not yet approved for general use outside of clinical trials.

What if I don't want to continue in the study?

You are free to leave the study at any time, for any reason, and this will not affect your future medical care.

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?

Register your interest

Share your details and the research team for "Study of Daraxonrasib and Daraxonrasib + GnP as First-line T…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.