Active not recruitingPHASE3INTERVENTIONAL

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

This study is comparing two medicines, ripretinib and sunitinib, for people with a type of cancer called GIST (Gastrointestinal Stromal Tumour). It's designed for people whose advanced GIST has certain genetic changes (in KIT exons 11 and 17/18) and has gotten worse despite previous treatment with imatinib. Researchers want to see if ripretinib is more effective than sunitinib. Participants will be randomly assigned to receive one drug or the other. If the GIST gets worse for those on sunitinib, they might have the option to switch to ripretinib.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Deciphera Pharmaceuticals, LLC

Enrolment target

Start

13 Dec 2023

Estimated completion

01 Dec 2028

GIST

What is this study about?

This study is for people who have advanced GIST, which stands for Gastrointestinal Stromal Tumour. GIST is a type of cancer that starts in the digestive system. We're looking for individuals whose GIST has specific changes in its genes, known as KIT exons 11 and 17/18 mutations. Importantly, participants in this study would have already been treated with a medicine called imatinib, and their GIST has unfortunately started to grow again or worsen.

The main goal of this study is to compare a new medicine, ripretinib, with a currently used medicine, sunitinib. Both of these are treatments for GIST. We want to find out which one works better at controlling the cancer in people with these specific genetic changes. This is a "Phase 3" study, which means it's one of the final steps before a new medicine might be approved for general use, so it's a very important stage of research.

Participants will be randomly assigned to receive either ripretinib or sunitinib. This helps ensure the comparison is fair. If someone is taking sunitinib and their GIST starts to get worse during the study, they might have the choice to switch over and try ripretinib. This study is happening in many places around the world and involves different hospitals and clinics.

Key takeaways

This study compares ripretinib to sunitinib for advanced GIST.
It's for people whose GIST has specific gene changes and has progressed after imatinib.
You will be randomly assigned to receive one of the two medicines.
Regular checks, blood tests, and scans will monitor your health and GIST.
If on sunitinib and GIST worsens, you might switch to ripretinib.
Always discuss risks and benefits with your medical team before deciding.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of GIST, specifically with gene changes called KIT exons 11 and 17/18 mutations. Your GIST must be advanced and have progressed after you've already had treatment with imatinib. You should also be generally well enough to take part in the study activities, as assessed by your doctor.

There are also some reasons why you might not be able to join. For example, if you have other specific GIST gene changes (like in KIT exon 9, 13, or 14), you won't be able to participate. Also, if you have certain serious heart problems, active cancer spread to your brain or spine, or some other major health conditions, the study might not be safe for you. If you're pregnant or planning to become pregnant, or if you're taking certain medications that could interact with the study drugs, you wouldn't be able to join.

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 advanced GIST?
Has your GIST progressed after treatment with imatinib?
Do you know if your GIST has KIT exon 11 and 17/18 gene changes (and not KIT exon 9, 13, or 14 changes)?
Are you generally well enough to participate in a study?
Do you have any serious heart conditions or active cancer spread to the brain?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly chosen to receive either ripretinib or sunitinib. This is like flipping a coin – neither you nor your doctor can choose which medicine you get. You'll take the study medicine as directed. Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans (like X-rays or CT scans) to see how your GIST is responding to the treatment and to monitor your general health. You will also be asked to provide blood samples to check for the specific gene changes in your GIST.

The length of your participation will depend on how your GIST responds to the treatment. If you are taking sunitinib and your GIST gets worse, you might have the option to switch to ripretinib. The doctors and nurses involved in the study will explain all the details and how often you'll need to attend appointments.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment, ripretinib, that might be more effective for your GIST than existing options, or it might help researchers learn more about how to treat GIST in the future. However, there are also potential risks, as all medicines can have side effects, and some might be serious. Sunitinib also has known side effects, and the side effects of ripretinib are still being fully understood. The study team will closely monitor you for any problems. Remember, joining a study is always your choice, and you are free to withdraw at any time without it affecting your usual medical care.

Locations (70)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UC San Diego Moores Cancer Center
Verified postcode
La Jolla, United States
Yale University
Verified postcode
New Haven, United States
Mayo Clinic Florida
Verified postcode
Jacksonville, United States
Sylvester Comprehensive Cancer Center
Verified postcode
Miami, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
Johns Hopkins Hospital
Verified postcode
Baltimore, United States
Boston Medical Center
Verified postcode
Boston, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States
M Health Fairview University of Minnesota Medical Center
Verified postcode
Minneapolis, United States
Mayo Clinic
Verified postcode
Rochester, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Northwell Health Cancer Institute/ R.J. Zuckerberg Cancer Center
Verified postcode
New York, United States

Common questions

What is GIST?

GIST stands for Gastrointestinal Stromal Tumour. It's a type of cancer that grows in the digestive system, most commonly in the stomach or small intestine.

What does 'KIT exon mutations' mean?

These are specific changes in the instructions (genes) inside your GIST cells. These changes can make the GIST grow, and certain medicines are designed to target them.

What is 'advanced GIST'?

Advanced GIST usually means the cancer has spread beyond its original location or has returned after previous treatment.

What happens if I'm on sunitinib and it doesn't work?

If your GIST gets worse while you're taking sunitinib in the study, you might have the choice to switch to ripretinib.

Why can't I have certain other gene changes and join?

This study is specifically looking at how ripretinib works for GIST with particular gene changes (KIT exons 11 and 17/18). If your GIST has other distinct gene changes like KIT exon 9, 13, or 14, the treatments might not work the same way, so you wouldn't be eligible for this specific study.