HC-1144

A review.The antitumor activity and safety of tivozanib, which is a potent and selective vascular endothelial growth factor receptor-1, -2, and -3 inhibitor, was assessed in patients with advanced/metastatic renal cell carcinoma (RCC).In this phase II, randomized discontinuation trial, 272 patients received open-label tivozanib 1.5 mg/d (one cycle equaled three treatment weeks followed by a 1-wk break) orally for 16 wk.Tivozanib was active and well tolerated in patients with advanced RCC.A unique attribute of this trial is the use of randomization of those patients who did not initially demonstrate objective response (more than 25% tumor reduction) or initially progress to continue to receive tivozanib or placebo.Among this group of minor responders and/or those with stable disease continuation of tivozanib resulted in a delay in time to disease progression.The importance of this finding applies when monitoring patients on chronic vascular endothelial growth factor directed therapy.