Purpose: The primary objective of this phase I trial was to establish the safety profile and pharmacokinetics of cixutumumab administered every 2 weeks (q2w) or every 3 weeks (q3w) in Japanese patients with advanced solid tumors. Exploratory analyses included preliminary antitumor activity.
Methods: Patients received intravenous cixutumumab q2w or q3w (6-week cycle) in a standard 3 + 3 study design.