Active not recruitingPHASE3INTERVENTIONAL

A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib

This research study is looking at two different medicines, ripretinib and sunitinib, for people with an advanced form of gastrointestinal stromal tumour (GIST). GIST is a rare type of cancer that affects the digestive system. All patients in this study will have already received a treatment called imatinib, but it either stopped working or they couldn't tolerate it. The study will randomly assign participants to receive either ripretinib or sunitinib, to see which drug is more effective. This is an international study, meaning people from different countries will be taking part. It's designed to help doctors understand the best way to treat GIST after imatinib.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Deciphera Pharmaceuticals, LLC

Enrolment target

453

Start

08 Feb 2019

Estimated completion

01 Dec 2026

Gastrointestinal Stromal Tumors

What is this study about?

This study is about finding better ways to treat a specific type of cancer called gastrointestinal stromal tumour, or GIST. This cancer can affect different parts of the digestive system. Doctors are particularly interested in patients whose GIST has advanced and who have already tried a common treatment called imatinib. For these patients, imatinib either stopped working or they had side effects that made them unable to continue taking it.

The study wants to compare two different medicines: ripretinib and sunitinib. Both of these are used to treat cancer. The main goal is to see which of these two medicines helps to control the GIST more effectively in patients who have already been treated with imatinib. By comparing them, researchers hope to learn which treatment can give patients a better outcome.

About 426 patients from different places around the world will take part. They will be split into two groups by chance (like flipping a coin). One group will receive ripretinib, and the other will receive sunitinib. This helps to ensure the results are fair and reliable. The findings from this study could help doctors make more informed decisions about the best treatment options for people with advanced GIST in the future.

Key takeaways

This study compares two drugs, ripretinib and sunitinib, for advanced GIST.
It's for patients whose previous treatment (imatinib) has stopped working or wasn't tolerated.
Patients will be randomly assigned to receive one of the two medicines.
The study aims to find a more effective treatment option for this patient group.
Your health will be closely monitored with regular check-ups and scans.

Who may be eligible?

To join this study, you must be at least 18 years old. You need to have a confirmed diagnosis of GIST, and doctors will need a sample of your tumour tissue to check specific details about your cancer.

An important requirement is that your GIST must have gotten worse while you were on imatinib, or you must have had problems taking imatinib because of side effects. Your overall health and ability to perform daily activities should also be reasonably good. We will check this using a standard health score.

For women who could become pregnant, a pregnancy test will be needed, and all participants capable of having children will need to agree to use effective contraception during the study. We will also check that your body’s main organs, like your kidneys and liver, are working well enough for you to take part.

Quick self-check

Are you 18 years old or older?
Do you have a confirmed GIST diagnosis?
Did your GIST get worse while on imatinib, or could you not take imatinib due to side effects?
Is your overall health and daily activity level reasonably good?
Are you willing to use contraception if you can have children?
Do you have a tumour that can be measured by scans?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be randomly assigned to receive either ripretinib or sunitinib. This means you will have a 50/50 chance of getting either medication, and you won't choose which one. You'll take your assigned medicine every day in cycles.

For example, if you're in the ripretinib group, you'll take 150 mg once a day continuously for six weeks, and then the next six-week cycle begins. If you're in the sunitinib group, you'll take 50 mg once a day for four weeks, then have a two-week break before starting the next six-week cycle.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Doctors will also track any side effects you might experience. The total duration of your participation will depend on how you respond to the treatment, but it will involve ongoing treatment cycles and follow-up.

Potential risks and benefits

Taking part in this study might offer a potential benefit if one of the study drugs helps to control your GIST better than other available treatments. However, there's no guarantee that you will personally benefit from taking part. Like all medications, both ripretinib and sunitinib can cause side effects. These could range from mild to more serious, and the study team will discuss these with you in detail. You are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (121)

Mayo Clinic Scottsdale
Scottsdale, United States
University of California San Diego Medical Center
La Jolla, United States
UCLA Hematology Oncology Center - Main Site
Los Angeles, United States
Stanford Medicine
Stanford, United States
University of Colorado Hospital - Anschutz Cancer Pavillion
Aurora, United States
Rocky Mountain Cancer Centers
Denver, United States
Smilow Cancer Hospital at Yale
New Haven, United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., United States
Mayo Clinic Florida
Jacksonville, United States
Sylvester Comprehensive Cancer Center
Miami, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, United States
Orlando Health UF Health Cancer Center
Orlando, United States

+109 more sites — see the official record for the full list.

Common questions

What is GIST?

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

Why is this study important?

This study is important because it aims to find out which treatment, ripretinib or sunitinib, works better for people with GIST whose initial treatment (imatinib) is no longer effective or couldn't be tolerated.

What does 'randomized' mean?

Randomized means you'll be assigned to one of the treatment groups (ripretinib or sunitinib) by chance, like drawing lots or flipping a coin. Neither you nor your doctor will decide which drug you receive.

Will I know which drug I'm getting?

Yes, this is an 'open-label' study, which means both you and your study doctor will know whether you are receiving ripretinib or sunitinib.

How long will I be in the study?

The length of your participation will depend on how your GIST responds to the treatment. You will continue to take the study drug as long as it is helping and you tolerate it well.