Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)
Status:
Completed
Trial end date:
2019-04-15
Target enrollment:
Participant gender:
Summary
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best
supportive care versus placebo plus best supportive care for subjects with metastatic and/or
unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite
prior treatment with at least imatinib and sunitinib.
The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival
Follow up Period.
Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of
every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive
best supportive care which excludes any disease specific anti cancer therapy such as any
kinase inhibitor, chemotherapy, radiation therapy, or surgery.
Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3
months (through month 6), and every 8 weeks until the end of treatment, or more frequently if
clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor
progression is seen in a central radiology review.
Subjects receiving placebo who experience disease progression may be offered active
treatment.
Subjects who experience progression during regorafenib treatment may continue open label
treatment.
All subjects will enter the Survival Follow-up Period upon discontinuation of randomized
study treatment.