Nirogacestat chez les femmes préménopausées atteintes de tumeur desmoïde/fibromatose agressive (DT/FA)
This study is for adult women, aged 18 to 40, who still have their period and have desmoid tumours that are growing. Desmoid tumours are rare, non-spreading growths that can still cause problems. The study is investigating a tablet called nirogacestat, which is already approved in the USA for this condition and works by slowing tumour growth. Researchers want to see how nirogacestat affects the ovaries, how well it treats the tumour, and if it causes any side effects. This study aims to help us better understand the safety and effectiveness of nirogacestat for women with desmoid tumours. It's important to remember that this medicine is approved in the USA, but may not be in the UK, and this study seeks to gather more information.
En un coup d'œil
De quoi parle cette étude ?
Desmoid tumours, sometimes called aggressive fibromatosis, are rare growths that develop in soft tissues like muscles and ligaments. While they are not cancerous in the way that they spread to other parts of the body, they can grow into surrounding tissues and cause a lot of pain and problems. These tumours can be quite serious for some people, even though they are considered 'benign' because they don't spread.
This study is looking at a new medicine called nirogacestat. This medicine is a tablet that you take by mouth, and it works by slowing down or stopping the growth of tumour cells. It has already been approved in the USA for adults with desmoid tumours that are getting worse and need treatment, but we need more information, especially for women in the UK.
The main aim of this study is to understand how nirogacestat might affect the ovaries of women who haven't yet reached menopause. Researchers also want to see how well it works to shrink or stop the growth of desmoid tumours, and to monitor any side effects people might experience. By taking part, you would be helping doctors learn more about this treatment and improve care for others with desmoid tumours in the future.
Points clés
- The study is for premenopausal women (18-40) with growing desmoid tumours.
- It tests nirogacestat tablets to see how they affect ovaries and tumour growth.
- Nirogacestat is already approved in the USA for this condition.
- Participation involves regular clinic visits, tests, and taking the study medicine.
- You can withdraw from the study at any time without affecting your normal care.
- This study helps doctors learn more about desmoid tumour treatment.
Qui peut être éligible ?
To join this study, you need to be a woman between 18 and 40 years old who still has regular periods. You must have a desmoid tumour that has been confirmed by a doctor and is causing symptoms or growing. You also need to be generally well enough to take part in a study, as assessed by a doctor.
There are certain reasons why you might not be able to join. For example, if you have severe heart problems, certain recent serious health events like a heart attack or stroke, or other types of cancer within the last five years (unless it was a very common skin cancer or similar that has been fully treated). You also can't take part if you have problems absorbing medicines from your gut or if your liver isn't working properly.
To ensure your safety, you'll need to use effective non-hormonal contraception during the study and for a period afterwards. You also cannot be pregnant or breastfeeding. These rules help make sure the study gathers accurate information and that you are as safe as possible.
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.
- Am I a woman aged between 18 and 40?
- Do I still have regular periods (not gone through menopause)?
- Have I been diagnosed with a desmoid tumour that is causing problems or growing?
- Am I willing to use effective non-hormonal contraception during the study?
- Do I have any serious heart conditions or other cancers in the past 5 years (excluding common treated skin cancers)?
- Do I have any problems absorbing medicines or severe liver issues?
En quoi consiste la participation ?
If you decide to take part in this study, you would be taking the study medicine, nirogacestat, as a tablet by mouth. The study involves a series of visits to the clinic over time. At these visits, doctors and nurses will carry out various checks, including blood tests, physical examinations, and scans to monitor your desmoid tumour and your overall health. They will pay close attention to your ovarian function to see how the medicine might be affecting your periods and hormone levels. You'll also be asked to report any side effects you experience.
The total duration of your participation in the study, including follow-up, will be decided by the researchers. It's important to remember that throughout the study, you'll have regular contact with the study team who will support you and answer any questions. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.
Risques et avantages potentiels
Locations (23)
- Cliniques Universitaires Saint-Luc (CUSL)Code postal vérifiéBruxelles, Belgique· Recrutement
- Universitaetsmedizin MannheimCode postal vérifiéMannheim, Germany· Recrutement
- IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.Code postal vérifiéMeldola, Italy· Recrutement
- La Fondazione e l'Istituto di CandioloCode postal vérifiéCandiolo, Italy· Recrutement
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant OrsolaCode postal vérifiéBologna, Italy· Recrutement
- IRCCS Istituto Ortopedico Rizzoli di BolognaCode postal vérifiéBologna, Italy· Recrutement
- Fondazione IRCCS Istituto Nazionale dei Tumori MilanoCode postal vérifiéMilan, Italie· Recrutement
- Istituto Nazionale Tumori I.R.C.C.S- Fondazione G. PascaleCode postal vérifiéNaples, Italy· Recrutement
- Policlinico Universitario Campus Bio-MedicoCode postal vérifiéRoma, Italy· Recrutement
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)Code postal vérifiéAmsterdam, Netherlands· Recrutement
- Academisch Ziekenhuis LeidenCode postal vérifiéLeiden, Netherlands· Recrutement
- Hospital de la Santa Creu i Sant PauCode postal vérifiéBarcelona, Spain· Recrutement
Questions fréquentes
What is a desmoid tumour?
A desmoid tumour is a rare growth that doesn't spread like cancer but can grow into surrounding tissues and cause problems.
What is nirogacestat?
Nirogacestat is a tablet medicine that aims to slow down or stop the growth of desmoid tumour cells.
Why is this study focusing on women's ovaries?
The study wants to understand if nirogacestat affects the ovaries and periods in women who haven't reached menopause yet.
Devrai-je payer pour participer à l'étude ?
No, all treatments, tests, and care directly related to the study are provided free of charge.
Puis-je quitter l'étude si je change d'avis ?
Yes, you can leave the study at any time, for any reason, without it affecting your other medical care.
Comment en savoir plus
US Medical Information
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Intéressé à participer ?
Discussion
Discussion communautaire
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