Treatment, DLT, and Determination of Maximum Tolerated Dose (MTD)
toxicity, DLTs
In the phase Ib study, a minimum of 3 enrolled patients per dose level was planned. No DLTs were reported in the first 3 patients enrolled at dose level 1 (ficlatuzumab 10 mg/kg) or 3 subsequent patients enrolled at dose level 2 (ficlatuzumab 20 mg/kg). Therefore, the regimen of gemcitabine 1000 mg/mIn total, 25 patients were assessable for toxicity, as summarized in Adverse toxicity profile (CTCAE v4.0) attributed to ficlatuzumab (