Spots Global Cancer Trial Database for Phase II Study of Regorafenib Continuous Dosing of Regorafenib in Patients With GISTs
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Trial Identification
Brief Title: Phase II Study of Regorafenib Continuous Dosing of Regorafenib in Patients With GISTs
Official Title: Phase II Study of Continuous Dosing of Regorafenib in Patients With Gastrointestinal Stromal Tumors (GISTs) After Failure of Imatinib and Sunitinib: GIST Regorafenib Continuous Dosing
Study ID: NCT02889328
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Asan Medical Center, University of Ulsan College of Medicine, Seoul, , Korea, Republic of
Contact Details
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