Abstract
10558Background: Axitinib is a small molecule that inhibits receptor tyrosine kinases VEGFR1-3. A phase I trial evaluating dose limiting toxicities (DLT), the maximally tolerated dose (MTD) and the pharmacokinetics (PK) of axitinib was conducted in children with refractory solid tumors. Methods: Oral axitinib tablets were administered bid, continuously in 28-day cycles. Dose levels 2.4 and 3.2 mg/m2/dose were evaluated using a rolling 6 design. Serial PK were obtained in Cycle 1. Results: As of December 11, 2015, 17 patients were enrolled with 1 ineligible (inadequate time from prior therapy). The median age was 14 yrs (range 5-17 yrs); 9 were male. Patients received a median 3 prior chemotherapy regimens (range 1-8). Cancer diagnoses included soft tissue sarcomas (7), Ewing (2) and osteosarcoma (1), neuroblastoma (2), Wilms tumor (1), hepatoblastoma (1), hepatocellular carcinoma (1), medullary carcinoma (1), and epithelial-myoepithelial carcinoma (1). Toxicity data are available for 15 patients (6 at dos...
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