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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


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT02712112 - A Study of Intermittent Dosing Schedule of Imatinib in Patients With Tyrosine Kinase Inhibitor Refractory GISTs Phase 2
Completed NCT03426722 - L-carnitine vs Placebo for the Treatment of Muscle Cramps After Imatinib in Gastrointestinal Stromal Tumors Phase 3
Recruiting NCT01768104 - ESTD vs. VATS for Upper Gastrointestinal Submucosal Tumors N/A