Purpose of this Study
If you choose to join this study, you will get a random assignment to 1 of 2 groups:
- One group will the study drug in combination with sunitinib
- The other group will get a placebo (inactive substance that has no drug in it) in combination with sunitinib
No matter to which group you are assigned, during the study you will:
- Have physical exams, electrocardiograms (ECG), and blood draws
- Have CT or MRI scans
You will visit our clinic for follow-up visits after you stop taking the study drugs, and we will keep in touch with you to see how you are feeling.
- One group will the study drug in combination with sunitinib
- The other group will get a placebo (inactive substance that has no drug in it) in combination with sunitinib
No matter to which group you are assigned, during the study you will:
- Have physical exams, electrocardiograms (ECG), and blood draws
- Have CT or MRI scans
You will visit our clinic for follow-up visits after you stop taking the study drugs, and we will keep in touch with you to see how you are feeling.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with metastatic gastrointestinal stromal tumors (GIST); OR
- Are diagnosed with a locally advanced form of GIST; OR
- Are with GIST and not a candidate for surgical resection
For more information on who can participate in this study please contact the study team at 919-681-4768.
- Are diagnosed with metastatic gastrointestinal stromal tumors (GIST); OR
- Are diagnosed with a locally advanced form of GIST; OR
- Are with GIST and not a candidate for surgical resection
For more information on who can participate in this study please contact the study team at 919-681-4768.
What is Involved?
We are doing this study to find out if a study drug called CGT9486 is a safe and effective option that can help people with locally advanced, unresectable, or metastatic GIST. We will compare how well the study drug works when it is combined with a standard drug, sunitinib.
Study Details
Principal Investigator
Richard
Riedel
Protocol Number
PRO00109902
NCT ID
NCT05208047
Phase
III
Enrollment Status
OPEN TO ACCRUAL