Randomized phase III trial of regorafenib in patients (pts) with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) progressing despite prior treatment with at least imatinib (IM) and sunitinib (SU) GRID trial

SUMMARY:Regorafenib is an oral multikinase inhibitor. In this randomized trial, patients with advanced GIST who had progressed on both GLEEVEC® (Imatinib) and SUTENT® (Sunitinib) were randomized to receive either Regorafenib or Placebo. The primary endpoint was progression-free survival (PFS). Patients in the Regorafenib group had a statistically significant 3.9 month improvement in progression-free survival (PFS) compared to placebo (4.8 months vs 0.9 months; Hazard Ratio = 0.27; P<.0001). Demetri GD, Reichardt P, Kang YK, et al. J Clin Oncol. 2012; 30 (suppl; abstr LBA10008).