Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)

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.

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.