Phase II Study of Regorafenib Continuous Dosing of Regorafenib in Patients With GISTs

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.

Timeline

Start

2016-09

Primary completion

2017-08-09

Completion

2018-01

Publications

• Kim JJ, Ryu MH, Yoo C, Beck MY, Ma JE, Kang YK. Phase II Trial of Continuous Regorafenib Dosing in Patients with Gastrointestinal Stromal Tumors After Failure of Imatinib and Sunitinib. Oncologist. 2019 Nov;24(11):e1212-e1218. doi: 10.1634/theoncologist.2019-0033. Epub 2019 Apr 29.

Drugs

Indications