Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
This research study is looking at a new medicine called belzutifan for people with advanced cancers like pheochromocytoma/paraganglioma (cancers of the adrenal glands or nerve cells), pancreatic neuroendocrine tumors (a type of pancreatic cancer), certain tumors related to Von Hippel-Lindau disease, or a specific type of advanced stomach cancer (GIST). It also includes other solid cancers with particular genetic changes. The main goal is to find out how effective belzutifan is at shrinking these tumors and if it's safe to use. This is a Phase 2 study, which means it builds on earlier research to gather more information on effectiveness and safety in a larger group of people.
En un coup d'œil
De quoi parle cette étude ?
This study is investigating a new medication called belzutifan, which is being tested for several advanced cancers. These include rare conditions like pheochromocytoma and paraganglioma, which are types of tumors often found in the adrenal glands or along nerve pathways. It's also for a specific kind of pancreatic cancer, certain tumors that develop in people with a genetic condition called Von Hippel-Lindau (VHL) disease, and a particular type of advanced stomach cancer. Finally, it covers other solid cancers that have a specific genetic change related to something called HIF-2α.
The main idea behind this research is to see if belzutifan can help shrink these tumors or stop them from growing. We also want to understand if it's safe and how people tolerate it. This is important because these cancers can be difficult to treat, and new options are always needed. Finding effective and safe treatments can make a big difference in people's lives.
This is a 'Phase 2' study. This means that belzutifan has already been tested in smaller groups of people and shown some promising results. In this phase, we are giving the medicine to a larger group to get more detailed information about its effectiveness and safety. The information we gather will help us decide if belzutifan could become a new treatment option in the future.
Points clés
- This study is testing a new medicine called belzutifan for several advanced cancers.
- It aims to see if belzutifan can shrink tumors and if it is safe.
- The study includes rare cancers like pheochromocytoma, paraganglioma, and certain pancreatic and stomach cancers.
- Participants must generally be at least 12 years old, with some exceptions for older ages.
- Regular hospital visits, tests, and scans will be part of the study monitoring.
- La participation est volontaire, et vous pouvez vous retirer à tout moment.
Qui peut être éligible ?
To join this study, participants generally need to be at least 12 years old, though for certain tumors related to Von Hippel-Lindau disease, you must be 18 or older. You must have one of the specific advanced cancers that the study is focusing on, and your doctors must believe you have at least three months to live.
There are also some reasons why you might not be able to join. For example, if you can't swallow pills, have trouble absorbing medicines, or have had another cancer in the last two years that wasn't fully cured. Your breathing and heart health are also important; if you need continuous oxygen or have serious heart problems, you might not be suitable.
Finally, if you've recently had other cancer treatments like chemotherapy, targeted drugs, or biological therapies within the last four weeks (except certain specific drugs for hormone-related issues), you would not be able to participate at this time.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Are you at least 12 years old (or 18 for certain conditions)?
- Do you have advanced pheochromocytoma/paraganglioma, pancreatic neuroendocrine tumor, VHL disease-associated tumors, or a specific type of advanced stomach cancer, or another solid cancer with a HIF-2α genetic change?
- Can you swallow pills without difficulty?
- Have you avoided other cancer treatments (except certain specific ones) in the last four weeks?
- Do you not require continuous oxygen and don't have severe heart problems?
En quoi consiste la participation ?
If you decide to take part in this study, you will receive the study medication, belzutifan. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor your health. These assessments help the doctors understand if the medicine is working and if there are any side effects. The exact number and frequency of visits will be explained by the study team, but they are designed to closely monitor your health and the progress of your cancer. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but it could involve ongoing treatment and follow-up for several months or longer.
Risques et avantages potentiels
Locations (84)
- Cedars-Sinai Medical Center ( Site 0110)Code postal vérifiéLos Angeles, États-Unis· Recrutement
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)Code postal vérifiéChicago, États-Unis· Recrutement
- Northwestern Medicine Cancer Center - Warrenville ( Site 0134)Code postal vérifiéWarrenville, United States· Recrutement
- University of Iowa ( Site 0104)Code postal vérifiéIowa City, États-Unis· Recrutement
- Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)Code postal vérifiéBaltimore, États-Unis· Recrutement
- National Institutes of Health ( Site 0125)Code postal vérifiéBethesda, United States· Recrutement
- Massachusetts General Hospital ( Site 0111)Code postal vérifiéBoston, États-Unis· Recrutement
- University of Michigan ( Site 0126)Code postal vérifiéAnn Arbor, États-Unis· Recrutement
- Washington University-Internal Medicine/Oncology ( Site 0124)Code postal vérifiéSaint Louis, États-Unis· Actif, mais pas en recrutement
- Icahn School of Medicine at Mount Sinai ( Site 0123)Code postal vérifiéNew York, États-Unis· Actif, mais pas en recrutement
- Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)Code postal vérifiéPhiladelphie, États-Unis· Actif, mais pas en recrutement
- SCRI Oncology Partners ( Site 7000)Code postal vérifiéNashville, United States· Terminé
Questions fréquentes
What is belzutifan?
Belzutifan is a new drug being tested in this study to see how it affects certain advanced cancers.
What types of cancer is this study for?
This study is for specific types of advanced cancers such as rare adrenal gland or nerve cell tumors, certain pancreatic and stomach cancers, and tumors linked to Von Hippel-Lindau disease, or other cancers with specific genetic changes.
What happens in a Phase 2 study?
In a Phase 2 study, a new medicine is given to a larger group of people to gather more details about how well it works and its safety.
Can children join this study?
Yes, some parts of the study are open to participants aged 12 and older, but for certain conditions, you must be at least 18.
Will I still receive my regular medical care?
Yes, taking part in a study will not affect your right to receive your usual medical care, and you can leave the study at any point.
Comment en savoir plus
Toll Free Number
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
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