Phase II Study of Continuous Dosing of Regorafenib in Patients With Gastrointestinal Stromal Tumors (GISTs) After Failure of Imatinib and Sunitinib

Phase II Study of Continuous Dosing of Regorafenib in Patients With Gastrointestinal Stromal Tumors (GISTs) After Failure of Imatinib and Sunitinib

Gastrointestinal Stromal Tumor

Completed

2

Start Date 09/01/2016

Age of Trial (yrs) 8.2

Gleevec-resistant

KIT/PDGFRA inhibitor

Block KIT + Block blood vessel growth

Specifically GIST and only GIST

AMC1602

Asan Medical Center

Yoon-Koo Kang, MD,PhD 82-2-3010-3230 ykkang@amc.seoul.kr Min-Hee Ryu, MD,PhD 82-2-3010-5935 miniryu@amc.seoul.kr

Oral

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.