(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.
Em resumo
Sobre o que é este estudo?
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).
Pontos principais
- 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.
Quem pode ser elegível?
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.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- 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?
- Você tem 18 anos ou mais?
- 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?
O que envolve a participação?
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.
Riscos e benefícios potenciais
Locations (126)
- Universidade do Alabama em BirminghamCódigo postal verificadoBirmingham, Estados Unidos· Retirado
- Clínica MayoCódigo postal verificadoScottsdale, Estados Unidos· Ativo, mas não recrutando
- University of Arizona- Cancer CenterCódigo postal verificadoTucson, Estados Unidos· Ativo, mas não recrutando
- Cidade da EsperançaCódigo postal verificadoDuarte, Estados Unidos· Ativo, mas não recrutando
- University of California, Los Angeles (UCLA)Código postal verificadoLos Angeles, Estados Unidos· Ativo, mas não recrutando
- University of California, San Diego (UCSD)Código postal verificadoSan Diego, Estados Unidos· Ativo, mas não recrutando
- Universidade da Califórnia, São FranciscoCódigo postal verificadoSão Francisco, Estados Unidos· Ativo, mas não recrutando
- University of Colorado DenverCódigo postal verificadoDenver, Estados Unidos· Ativo, mas não recrutando
- MedStar Washington Hospital CenterCódigo postal verificadoWashington D.C., Estados Unidos· Recrutamento
- Mayo Clinic JacksonvilleCódigo postal verificadoJacksonville, Estados Unidos· Ativo, mas não recrutando
- University of Miami - Sylvester Comprehensive Cancer CenterCódigo postal verificadoMiami, Estados Unidos· Recrutamento
- Mid Florida Hematology and Oncology CenterCódigo postal verificadoOrange City, United States· Retirado
Perguntas frequentes
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.
Saberei qual tratamento estou recebendo?
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.
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Cogent Biosciences
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