Basic Aspects and Clinical Trials of Micelle Carrier System

NK911 is the first successful polymeric micelle system directed to remarkable accumulation in solid tumor through 5PR affect. The micelle consists of block copolymer of polyethylene glycol (PEG) and poly (aspartic acid) partially conjugated doxorubicin. The main objectives of this phase I study were to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and the recommended dose (RD) for phase II given every 3 weeks as a 10 mg DXR equivalent/min iv infusion to patients with solid tumors. Dose escalation is based on the accelerated titration method followed by a modified Fibonacci method. The starting dose was 6.0 mg/m2 (1/10 of rat LD10). No intrapatient dose escalation was allowed.