LUME-Colon 1: A double-blind, randomized phase III study of nintedanib plus best supportive care (BSC) versus placebo plus BSC in patients with colorectal cancer (CRC) refractory to standard therapies.

2015 ◽  
Vol 33 (15_suppl) ◽  
pp. TPS3625-TPS3625 ◽  
Author(s):  
Heinz-Josef Lenz ◽  
Josep Tabernero ◽  
Takayuki Yoshino ◽  
Zohra Oum'Hamed ◽  
Soetkin Vlassak ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Supportive Care ◽  
Best Supportive Care ◽  
Phase Iii ◽  
Double Blind ◽  
Phase Iii Study

scholarly journals FRESCO-2: a global Phase III study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer

2021 ◽  
Author(s):  
Arvind Dasari ◽  
Alberto Sobrero ◽  
James Yao ◽  
Takayuki Yoshino ◽  
William Schelman ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Supportive Care ◽  
Metastatic Colorectal Cancer ◽  
Kinase Inhibitor ◽  
Progression Free Survival ◽  
Best Supportive Care ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Phase Iii Study

Fruquintinib, a novel, highly selective, small-molecule tyrosine kinase inhibitor of VEGF receptors (VEGFRs)-1, -2 and -3, is approved in China for the treatment of metastatic colorectal cancer. FRESCO-2, a global, randomized, double-blind, placebo-controlled, Phase III study, is investigating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Key inclusion criteria include: progression on or intolerance to TAS-102 and/or regorafenib; and prior treatment with approved chemotherapy, anti-VEGF therapy, and, if RAS wild-type, anti-EGFR therapy. Approximately 687 patients will be randomized 2:1 to fruquintinib plus best supportive care or placebo plus best supportive care. Primary and key secondary end points are overall survival and progression-free survival, respectively. FRESCO-2 is enrolling in the USA, Europe, Australia and Japan.

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