In a randomized phase III trial, patients with refractory advanced colorectal cancer were randomized (1:1 ratio) to receive BBI608 (n = 138) vs. placebo (n = 144) after stratification by performance status, kirsten rat sarcoma viral oncogene homolog (KRAS) status, prior vascular endothelial growth factor inhibitor treatment, and time from diagnosis of metastatic disease. This evidence concerns the gene KRAS and metastatic neoplasm.