A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)
This research study is looking at a type of cancer called Gastrointestinal Stromal Tumour (GIST), which grows in the digestive system, usually the stomach or small intestine. This cancer happens when certain cells grow too much. While current treatments help, sometimes the cancer stops responding, so we need new options. This study is for adults whose GIST has recently been diagnosed and has either spread to other parts of the body or cannot be removed by surgery. We are comparing a new medicine, velzatinib, with imatinib, which is the standard treatment. The main goal is to find out if velzatinib can stop the cancer from getting worse for longer, and if it's safe and well-tolerated.
Em resumo
Sobre o que é este estudo?
Gastrointestinal Stromal Tumour (GIST) is a type of cancer that starts in the digestive system, most often in the stomach or small intestine. It happens when cells in these areas grow out of control, forming a tumour. Even though we have treatments for GIST, sometimes they stop working over time, so doctors are always looking for new and better ways to help people.
This study is called 'StrateGIST Frontline' and it's for adults who have just been diagnosed with GIST that has either spread to other parts of the body (called 'metastatic') or cannot be completely removed with an operation. The study aims to test a new medicine called velzatinib. It will be compared against imatinib, which is the usual first-choice treatment for GIST.
The main reasons for doing this study are to see if velzatinib can keep the cancer from getting worse for a longer time compared to imatinib, and to check if it's safe and doesn't cause too many side effects. This research could help us find a new treatment option for people with GIST.
Pontos principais
- This study tests a new GIST medicine, velzatinib, against the usual treatment, imatinib.
- It's for adults newly diagnosed with GIST that has spread or can't be surgically removed.
- The main goals are to see if velzatinib delays cancer worsening and is safe.
- Participants will be randomly assigned to one of the two medicines.
- Regular hospital visits and tests will be needed to monitor health and treatment response.
Quem pode ser elegível?
To join this study, you need to be at least 18 years old and have GIST that has been confirmed by a doctor. Your GIST must have spread or not be removable by surgery, and you shouldn't have had any other treatment for this type of GIST before.
Doctors will also need to get a sample of your tumour tissue, either an old one from when you were first diagnosed or a new one. You must be well enough for a clinical trial, and your body's organs (like your liver and kidneys) need to be working properly. If you are able to have children, you and your partner will need to use reliable contraception throughout the study and for a period afterwards.
You cannot join if you have another type of cancer that has recently been active or needed treatment, or if you are pregnant or breastfeeding. The medical team will check all these points carefully to make sure the study is right and safe for you.
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.
- Você tem pelo menos 18 anos?
- Do you have GIST that has spread or cannot be removed by surgery?
- Have you not had any prior treatment for this spread GIST?
- Are you well enough for a clinical trial, and are your organs working properly?
- If you can have children, are you willing to use reliable contraception?
- Are you able to provide a tumour tissue sample?
O que envolve a participação?
If you decide to take part in this study, you'll be randomly assigned to receive either the new medicine, velzatinib, or the standard medicine, imatinib. This means you won't get to choose which one you receive, similar to flipping a coin.
Your participation will involve regular visits to the clinic for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor your health. You will also have to take the study medicine as prescribed. The medical team will explain the full schedule of visits and tests during the study.
We don't have information on the total duration of the study or the exact number of visits from the brief details provided, but these will be clearly explained by the study team. You will be closely monitored by doctors and nurses throughout the study.
Riscos e benefícios potenciais
Localizações (93)
- Site de Investigação da GSKCódigo postal verificadoScottsdale, Estados Unidos· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoSão Francisco, Estados Unidos· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoNew Haven, Estados Unidos· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoBethesda, Estados Unidos· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoKansas City, Estados Unidos· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoOmaha, Estados Unidos· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoNova Iorque, Estados Unidos· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoDurham, Estados Unidos· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoCanton, United States· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoKnoxville, United States· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoHouston, Estados Unidos· Recrutamento
- Site de Investigação da GSKCódigo postal verificadoSeattle, Estados Unidos· Recrutamento
Perguntas frequentes
What is GIST?
GIST is a type of cancer that grows in your digestive system, most commonly in the stomach or small intestine.
Por que este estudo é importante?
Current treatments for GIST can stop working over time, so this study aims to find a new, potentially better medicine (velzatinib) to help people whose cancer has spread or can't be removed by surgery.
O que significa 'Fase 3' para um ensaio clínico?
Phase 3 means this medicine has already been tested in smaller groups and is now being compared to the standard treatment in a larger group of patients to confirm its effectiveness and safety.
Saberei qual medicamento estou recebendo?
No, you will be randomly assigned to receive either velzatinib or imatinib, like drawing lots. Neither you nor the doctors will know which one you are taking until after the study is complete, unless there's a medical need to find out.
What if I want to stop participating?
You are free to leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.
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