A Study of AL102 in Patients With Progressing Desmoid Tumors
This research is investigating a new treatment called AL102 for desmoid tumours that are getting larger. Desmoid tumours are rare, non-cancerous growths that can cause pain and problems. The study, which includes two main phases, will first help doctors find the best dose of AL102. Afterwards, it will compare AL102 to a placebo (a treatment with no active drug) to understand how effective and safe it is. This is important to help find better ways to manage these challenging tumours and improve people's quality of life. The study aims to provide clearer answers about AL102 as a potential new option.
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¿De qué trata este estudio?
This study is focused on people who have desmoid tumours that are growing or causing problems. Desmoid tumours are unusual growths that, while not cancerous, can be difficult to manage because they can grow quite large and cause pain or affect how your body works. The new medication being tested in this study is called AL102. Researchers want to find out two main things: whether it works to stop or slow the growth of these tumours, and if it's safe for people to take.
The study is split into two main parts. The first part is like a fact-finding mission where doctors will try out different doses of AL102 to figure out which one works best and is easiest to tolerate. Once they've found the best dose, the study moves into a second, larger part. In this part, some participants will receive AL102, and others will receive a 'placebo' – this is an inactive substance that looks just like the real medicine but contains no drug. This helps researchers understand if any improvements are genuinely due to AL102 or if they might happen anyway.
The overall goal of this research is to see if AL102 could become a valuable new treatment option for people living with desmoid tumours. By understanding its effects, doctors can make more informed decisions about how to help their patients, potentially offering a new way to manage these often challenging growths and improve patients' daily lives.
Puntos clave
- This study is testing a new medication, AL102, for growing desmoid tumours.
- It aims to find the best dose and compare AL102 to a placebo to check its effectiveness and safety.
- Participants must be at least 18 with a confirmed, progressing desmoid tumour.
- Regular hospital visits, scans, and blood tests will be part of the participation.
- There's a potential benefit of receiving a new treatment, but also possible side effects or receiving a placebo.
- Puede retirarse del estudio en cualquier momento.
¿Quién puede ser elegible?
To join this study, you need to be at least 18 years old and have a desmoid tumour that has been confirmed by a doctor. Your tumour must also be getting bigger, either by growing at least 10% in size over 18 months, or by causing pain that isn't controlled by regular painkillers.
It's important that you haven't been diagnosed with any other cancer in the last two years (with some specific exceptions), and you shouldn't have certain gut problems that could affect how the medicine is absorbed, or make you more prone to diarrhoea. You also shouldn't have any serious uncontrolled infections or severe heart problems.
Basically, the study is looking for adults with growing desmoid tumours who are generally in reasonable health, can swallow capsules, and do not have certain other serious medical conditions that might make the treatment unsafe or difficult to assess.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Tienes al menos 18 años?
- Has a doctor confirmed you have a desmoid tumour that is currently growing?
- Do you generally feel well and not have other serious medical conditions like heart problems or recent cancer?
- Can you swallow capsules whole?
- Are you able to attend regular hospital appointments for check-ups and scans?
¿En qué consiste la participación?
If you join this study, you'll first have some tests to make sure you're suitable. The study has two main parts. In the first part, you'll receive AL102, and doctors will carefully adjust the dose to find the best one. In the second part, you might receive AL102 or a 'dummy' tablet (placebo) – you won't know which one you're getting. You'll have regular hospital visits for check-ups, scans (like MRI to measure your tumour), and blood tests. You'll need to be able to swallow capsules whole, as the medication is taken by mouth. The total duration of your participation will depend on the study's progress and your individual situation, including follow-up visits after treatment ends.
Riesgos y beneficios potenciales
Ubicaciones (53)
- Mayo ClinicSolo ciudadPheonix, United States
- City of HopeCódigo postal verificadoDuarte, Estados Unidos
- Sarcoma Oncology Research CenterCódigo postal verificadoSanta Mónica, Estados Unidos
- University of California at Los Angeles Hematology/OncologyCódigo postal verificadoSanta Mónica, Estados Unidos
- Stanford University Medical CenterCódigo postal verificadoStanford, United States
- Mayo ClinicCódigo postal verificadoJacksonville, Estados Unidos
- NorthShore University Health SystemCódigo postal verificadoEvanston, United States
- Hospital General de MassachusettsCódigo postal verificadoBoston, Estados Unidos
- University of MichiganCódigo postal verificadoAnn Arbor, Estados Unidos
- Jefferson City Medical GroupCódigo postal verificadoJefferson City, United States
- Washington UniversityCódigo postal verificadoSan Luis, Estados Unidos
- Columbia University Irving Medical CenterCódigo postal verificadoNueva York, Estados Unidos
Preguntas comunes
What is a desmoid tumour?
A desmoid tumour is a rare type of growth that is not cancerous but can be aggressive, growing into nearby tissues and causing problems like pain.
¿Qué es un placebo?
A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps researchers fairly compare the new drug's effects.
Will I know if I'm getting the active drug or the placebo?
In the second part of the study, neither you nor your doctors will know if you're receiving the active drug (AL102) or the placebo. This is called 'double-blind'.
How is AL102 taken?
AL102 is taken by mouth as capsules. You must be able to swallow them whole.
¿Puedo abandonar el estudio si cambio de opinión?
Yes, you can decide to stop participating in the study at any time, for any reason, without affecting your regular medical care.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.