PEAK (Gastrointestinal Stromal Tumors) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Locally Advanced, Unresectable, and/or Metastatic Gastrointestinal Stromal Tumors (GIST)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with metastatic gastrointestinal stromal tumors (GIST); OR
  • Are diagnosed with a locally advanced form of GIST; OR
  • Are diagnosed 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.

Age Group

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

Full Title
A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00109902
NCT: NCT05208047
Phase III
Enrollment Status
Open for Enrollment