Active not recruitingPHASE3INTERVENTIONAL

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

This research focuses on advanced Gastrointestinal Stromal Tumors (GIST), a type of cancer in the stomach or intestines. It's a large study, involving hundreds of patients, to see if a new drug, CGT9486 (also known as bezuclastinib), when given with an existing medicine called sunitinib, is more effective than sunitinib on its own. The study is for people whose GIST has progressed or who can't tolerate their current treatment. It also aims to confirm the best dose of the new drug and understand how it interacts with other medications. Additionally, a small part of the study will look at using bezuclastinib and sunitinib as a first treatment for a specific type of GIST.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Cogent Biosciences, Inc.

Enrolment target

482

Start

14 Apr 2022

Estimated completion

01 Jan 2030

Advanced Gastrointestinal Stromal Tumors Metastatic Cancer

What is this study about?

This study, called "Peak," is investigating new treatments for a type of cancer known as Gastrointestinal Stromal Tumors, or GIST. GIST is a cancer that starts in the digestive tract, most commonly in the stomach or small intestine. When GIST is advanced, meaning it has spread or can't be removed with surgery, doctors look for medicines to help control its growth.

The main goal of this study is to compare two treatment approaches. One group of patients will receive a new drug called CGT9486 (which you might also hear referred to as bezuclastinib) along with an existing drug called sunitinib. The other group will receive sunitinib on its own. Researchers want to see if the combination of drugs works better at slowing down or stopping the cancer's growth for patients who haven't responded well to previous treatments, particularly imatinib, or who couldn't tolerate it.

Before comparing the treatments, the study will first check the best dose of the new CGT9486 drug and understand how it interacts with other medicines in a smaller number of patients. There are also smaller parts of the study looking at other aspects, such as how CGT9486 might affect other drugs in the body, and even exploring if bezuclastinib and sunitinib could be a good first treatment for a specific type of GIST, particularly if it has a certain genetic change (called a KIT exon 9 mutation).

Key takeaways

Tests a new GIST drug (CGT9486) with an existing one (sunitinib).
Aims to find better options for advanced GIST, especially after other treatments fail.
Compares the new drug combination against sunitinib alone.
Includes assessment of side effects and drug interactions.
Could help patients whose cancer has progressed or who can't tolerate current treatments.
Participation results are carefully monitored.

Who may be eligible?

To join this study, you would typically need to have been diagnosed with GIST that is advanced, has spread, or can't be removed by surgery. For most parts of the study, your GIST should have either worsened after taking a standard drug called imatinib, or you should have found imatinib difficult to tolerate.

Your general health also plays a part. You should be fairly active and able to look after yourself, as measured by a score doctors use to assess your daily activity level (this is called ECOG). Your blood tests for routine checks like kidney and liver function should be within acceptable limits. You must be at least 18 years old. For some specific parts of the study, your GIST might need to have a particular genetic change.

Quick self-check

Have you been diagnosed with GIST that is advanced, has spread, or cannot be removed?
Has your GIST progressed on imatinib treatment, or did you find imatinib difficult to tolerate?
Are you 18 years old or older?
Are you generally able to carry out your daily activities (an ECOG score of 0-2)?
Are your routine blood tests (liver, kidney function) within acceptable limits?
Do you have at least one measurable area of cancer?

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

What does participation involve?

If you decide to take part in this study, you would first go through screening tests to make sure you're suitable. Once accepted, you'd be given either the combination of CGT9486 and sunitinib or sunitinib by itself. This will be decided by chance, like flipping a coin. You will have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Some visits might include specific tests to see how the drugs are working in your body. The study involves taking medication, and you'll be followed closely by the study team. They will explain exactly how often you need to attend and for how long, but studies like this can often last for many months, sometimes years, with ongoing follow-up.

Potential risks and benefits

Taking part in this study means you could potentially benefit from a new treatment combination that might work better for your GIST than existing options, helping to control your cancer for longer. However, there are also risks, as all medications can have side effects. These will be fully explained to you before you consider joining. The study drugs may cause unwanted reactions, some of which could be serious. You will be closely monitored for any side effects. Remember, joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (110)

Mayo Clinic
Scottsdale, United States
University of Arizona- Cancer Center
Tucson, United States
City of Hope
Duarte, United States
University of California, Los Angeles (UCLA)
Los Angeles, United States
University of California, San Diego (UCSD)
San Diego, United States
University of California, San Francisco
San Francisco, United States
University of Colorado Denver
Denver, United States
MedStar Washington Hospital Center
Washington D.C., United States
Mayo Clinic Jacksonville
Jacksonville, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, United States
Orlando Health Cancer Institute
Orlando, United States
Moffitt Cancer Center
Tampa, United States

+98 more sites — see the official record for the full list.

Common questions

What is GIST?

GIST stands for Gastrointestinal Stromal Tumor, a rare type of cancer that starts in the digestive tract, most often the stomach or small intestine.

What does 'advanced' or 'metastatic' mean?

This means the cancer has either grown locally in a way that makes it hard to remove, or it has spread to other parts of the body.

What is sunitinib?

Sunitinib is an existing medication used to treat certain cancers, including GIST, when other treatments haven't worked or can't be tolerated.

Will I know which treatment I'm getting?

Yes, in the main part of this particular study, you will know whether you are receiving the combination of CGT9486 plus sunitinib or sunitinib alone, as it's an 'open-label' study.

What happens if I decide to stop participating?

You are free to leave the study at any time without having to give a reason. This will not affect the medical care you receive.