A Non-randomized, Open Label, Multi-center Phase II Study Evaluating the Efficacy and Safety of Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST), Resistent or Intolerant to at Least Imatinib and Sunitinib
- In this research study, each planned "cycle" of the study lasts 4 weeks. In the first
cycle, participants will come to the clinic on Days 1, 15 and 16. For cycles 2 through
4, they will come to the clinic on Days 1 and 15 of each cycle. For cycle 5 and
beyond, they will come to the clinic on Day 1 of each cycle. Repeat tumor imaging will
be performed at the end of every 2 cycles during study drug administration (e.g. end of
cycles 2, 4, 6, etc.)
- During each cycle, participants will take regorafenib by mouth, once a day in the
morning, for 3 weeks followed by one week during which you do not take regorafenib (the
- FDG-PET/CT (Positron Emission Tomography) scans are required as part of this study to
monitor effects of the study drug on the participant's GIST. The first scan will take
place before the first dose of study drug. If the first scan shows that the "tracer
sugar" collection is increased in the participant's GIST, they will have up to 5
additional scans performed at different time points throughout their participation in
this research study.
- Participants may continue to participate in this research study for as long as they do
not have serious side effects or their disease does not get worse.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess clinical benefit as defined by the composite of complete response, partial response and stable disease lasting 16 weeks or more per RECIST 1.1 as a measure of disease control.
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Oregon Health Sciences University||Portland, Oregon|