Table 2.

Planned dose levels and observed DLTs

Dose level	Figitumumaba	Paclitaxel (mg/m2)	Carboplatin (mg·min/mL)	N	DLTs
1	6 mg/kg	200	6	6	Grade 4 thrombocytopenia (n = 1)
2	10 mg/kg	200	6	7	Grade 3: hyperkalemia, hypermagnesemia, hyponatremia; grade 4 hyperuricemia (n = 1) Grade 4 thrombocytopenia (n = 1)
3	20 mg/kgb	200	6	6	None

DLT dose-limiting toxicity

^aIf none of the three patients in the 6 mg/kg cohort experienced a DLT during cycle 1, subjects were enrolled onto the next dose level. If one DLT was observed, the cohort was to be expanded to six patients. If none of the three or two or less of the six patients experienced a DLT, then dose escalation was to be continued and three patients were enrolled to the 10 mg/kg cohort. In a similar manner depending on observed DLTs, the 10 mg/kg cohort could be expanded to six patients and dose escalation continued to a 20 mg/kg cohort of six patients. If two or more of the three, or three or more of the six patients experienced a DLT, dose escalation would be stopped

^bSix patients dosed, and 20 mg/kg deemed tolerable if two or fewer of the six patients experienced a DLT