A phase I dose escalation and pharmacokinetic (PK) study of intravenous (iv) aflibercept (VEGF Trap) plus weekly gemcitabine (Gem) in patients (pts) with advanced solid tumors: preliminary results

3558 Background: Aflibercept (AF) is a recombinant fusion protein that is a potent inhibitor of vascular endothelial growth factor (VEGF). This study was designed to assess the safety/tolerability, dose-limiting toxicities (DLTs), recommended Phase II dose, and PK of AF plus Gem. Methods: This combination trial explored escalating iv doses of AF, administered every 2 weeks(q2w), followed by standard weekly iv Gem (7w on/1w off, then 3w on/1w off every 4w). Results: 32 pts (M/F 9/23, median age 58 [38–75], ECOG-PS 0/1/2: 10/21/1) were enrolled in 2 AF dose levels: 4.0 (n = 20) and 6.0 (n = 12) mg/kg. Primary tumors included pancreas (11), breast (7), sarcoma (3), and others (11). Most (9/11) pancreatic pts were first-line. Other pts were heavily pre-treated, with a median of 3[1–11] prior lines. Pts received a median of 2 [1–9] 4w treatment cycles (cy). During the dose escalation phase, no AF-related DLT (first 4w cy) was observed. Gr > 3 NCI-CTCAE toxicities observed across doses included: neutropenia (34...