Treatment schema based on UGT1A1 genotype.
aPatients were also tested for the UGT1A1*6 variant
bThe following did not constitute a DLT: Grade 3 nausea, vomiting or diarrhea occurring without optimal medical management; grade 3 or 4 nausea, vomiting or diarrhea that resolves (grade </= 2) within 48 hours; elevated amylase or lipase in the absence of clinical signs or symptoms of pancreatitis, grade 3 hyperglycemia, abnormalities of liver function tests clearly related to malignant biliary obstruction, or other grade 3 AEs deemed clinically insignificant (such as laboratory abnormalities not requiring therapeutic intervention or change in management).