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

Gastrointestinal Stromal Tumors (GISTs) Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• Gastrointestinal Stromal Tumors (GISTs)

• NCT number: NCT02889328
• Study type: Interventional
• Source: Asan Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: September 2016
• Completion date: January 2018