Phase II Study of Regorafenib Continuous Dosing of Regorafenib in Patients With GISTs
Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
Summary
Randomized, placebo-controlled, phase III study of regorafenib 160 mg once daily on
intermittent dosing schedule of 3 weeks on treatment followed by 1 weeks off demonstrated the
significant benefit of regorafenib in terms of PFS in patients with GISTs who had failed to
both imatinib and sunitinib. However, there are concerns that tumors and tumor-related
symptoms may be progressed during off treatment period. Investigators hypothesize that
continuous dosing schedule of regorafenib might be feasible and effective to prevent disease
flare on off-treatment period. Based on the results of previous dose escalation study for
continuous regorafenib dosing, we investigate the 100 mg daily dose of regorafenib in
patients with TKI-refractory GISTs.