A Study of the Safety and Tolerability in Participants With PIK3CA-related Overgrowth Spectrum or Proteus Syndrome Who Are Being Treated With Miransertib (MK-7075) in Other Studies (MK-7075-006)

To join this study, you must be at least 2 years old and have a diagnosis of PIK3CA-related overgrowth spectrum (PROS) or Proteus Syndrome. You'll likely be eligible if you're already taking Miransertib in a different study, or if you've been approved to start in one of those studies but haven't started yet.

There are also some important rules around contraception. Men must agree to use effective contraception or avoid sex during the study and for 3 months after their last dose. Women who could become pregnant must also use very effective contraception or avoid sex. Women who are pregnant or breastfeeding cannot take part.

However, you won't be able to join if you've had to stop taking Miransertib before because of serious side effects or if it wasn't tolerable for you. You also cannot be taking certain other medications, such as specific growth pathway inhibitors, medicines that weaken your immune system, or continuous high doses of steroids.

If you decide to take part in this study, you'll be taking Miransertib, likely continuing from a previous study. You'll have regular visits to the study clinic where the research team will monitor your health. These visits will involve check-ups, probably blood tests, and discussions about how you're feeling and any side effects you might be having. The researchers will be looking closely at how your body responds to the medicine and if you experience any unexpected issues. The total duration of your participation would depend on your original study and how long this extension study runs, but it aims to gather long-term safety data.