(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

To join this study, you would typically need to have been diagnosed with GIST that is advanced, has spread, or can't be removed by surgery. For most parts of the study, your GIST should have either worsened after taking a standard drug called imatinib, or you should have found imatinib difficult to tolerate.

Your general health also plays a part. You should be fairly active and able to look after yourself, as measured by a score doctors use to assess your daily activity level (this is called ECOG). Your blood tests for routine checks like kidney and liver function should be within acceptable limits. You must be at least 18 years old. For some specific parts of the study, your GIST might need to have a particular genetic change.

If you decide to take part in this study, you would first go through screening tests to make sure you're suitable. Once accepted, you'd be given either the combination of CGT9486 and sunitinib or sunitinib by itself. This will be decided by chance, like flipping a coin. You will have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. Some visits might include specific tests to see how the drugs are working in your body. The study involves taking medication, and you'll be followed closely by the study team. They will explain exactly how often you need to attend and for how long, but studies like this can often last for many months, sometimes years, with ongoing follow-up.