NCT02889328

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Stromal Tumors (GISTs)

Interventions

Type	Name	Description
DRUG	Regorafenib	Regorafenib 100mg continuous dosing arm

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-08-09
• Completion: 2018-01-01
• First posted: 2016-09-05
• Last updated: 2020-01-09

Locations

1 site across 1 country: South Korea