Abstract
10058 Background: Crizotinib is a small molecule inhibitor of the c-Met/HGFR, ALK, and ROS1 receptor tyrosine kinase (RTK). The Children’s Oncology Group (COG) Phase I study of crizotinib determined the recommended phase 2 dose (RP2D) to be 280 mg/m2/BID. Objective tumor responses in patients with known activating ALK aberrations were demonstrated. This phase I study aims to determine the safety, tolerability and RP2D of crizotinib in combination with conventional chemotherapy for children with refractory solid tumors and ALCL. Methods: Pediatric patients with measurable or evaluable solid tumors or ALCL, refractory to therapy were eligible. Using a 3+3 design, crizotinib was escalated in 3 dose levels from 165 mg/m2/dose to the RP2D of 280 mg/m2/dose BID. Patients were enrolled on either Part A, crizotinib with topotecan and cyclophosphamide, or Part B, crizotinib with vincristine and doxorubicin. The oral solution of crizotinib was used for all patients. In part C of the study, patients received crizoti...
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