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RekrutierungPHASE2INTERVENTIONELL

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.

Auf einen Blick

Status
Rekrutierung
Phase
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Einschreibeziel
355
Starten
12. Aug. 2021
Geschätzte Fertigstellung
18 Nov 2032

Worum geht es in dieser Studie?

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.

Wichtige Erkenntnisse

  • 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.
  • Die Teilnahme ist freiwillig, und Sie können jederzeit zurücktreten.

Wer könnte berechtigt sein?

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.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Are you at least 12 years old (or 18 for certain conditions)?
  2. 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?
  3. Can you swallow pills without difficulty?
  4. Have you avoided other cancer treatments (except certain specific ones) in the last four weeks?
  5. Do you not require continuous oxygen and don't have severe heart problems?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

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.

Potenzielle Risiken und Vorteile

Taking part in any clinical trial has potential benefits and risks. You might benefit from the study treatment if belzutifan is effective for your type of cancer, potentially slowing its growth or shrinking it. However, there's no guarantee the treatment will work for you, and you might experience side effects, as with any medication. These side effects will be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Standorte (84)

  • Cedars-Sinai Medical Center ( Site 0110)
    Verifizierte Postleitzahl
    Los Angeles, Vereinigte Staaten· Rekrutierung
  • Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)
    Verifizierte Postleitzahl
    Chicago, Vereinigte Staaten· Rekrutierung
  • Northwestern Medicine Cancer Center - Warrenville ( Site 0134)
    Verifizierte Postleitzahl
    Warrenville, United States· Rekrutierung
  • University of Iowa ( Site 0104)
    Verifizierte Postleitzahl
    Iowa City, Vereinigte Staaten· Rekrutierung
  • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)
    Verifizierte Postleitzahl
    Baltimore, Vereinigte Staaten· Rekrutierung
  • National Institutes of Health ( Site 0125)
    Verifizierte Postleitzahl
    Bethesda, Vereinigte Staaten· Rekrutierung
  • Massachusetts General Hospital ( Site 0111)
    Verifizierte Postleitzahl
    Boston, Vereinigte Staaten· Rekrutierung
  • University of Michigan ( Site 0126)
    Verifizierte Postleitzahl
    Ann Arbor, Vereinigte Staaten· Rekrutierung
  • Washington University-Internal Medicine/Oncology ( Site 0124)
    Verifizierte Postleitzahl
    St. Louis, Vereinigte Staaten· Aktiv, aber nicht rekrutierend
  • Icahn School of Medicine at Mount Sinai ( Site 0123)
    Verifizierte Postleitzahl
    New York, Vereinigte Staaten· Aktiv, aber nicht rekrutierend
  • Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)
    Verifizierte Postleitzahl
    Philadelphia, Vereinigte Staaten· Aktiv, aber nicht rekrutierend
  • SCRI Oncology Partners ( Site 7000)
    Verifizierte Postleitzahl
    Nashville, Vereinigte Staaten· Abgeschlossen

Häufige Fragen

What is belzutifan?

Belzutifan is a new drug being tested in this study to see how it affects certain advanced cancers.

Für welche Krebsarten ist diese Studie?

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.

Wie Sie mehr erfahren können

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