A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults with Relapsed or Refractory Osteosarcoma (OLIE)

Osteosarcoma is the most commonly diagnosed primary malignancy of the bone in children and young adults, and accounts for approximately 5% of childhood tumours in people younger than 24 years. Disappointingly, there has been no substantial progress in the treatment of osteosarcoma since the 1980s. About 30% to 40% of patients with localised disease and 80% of those with metastatic disease experience relapse. Studies have demonstrated that several genetic abnormalities, including the overexpression of vascular endothelial growth factor (VEGF) receptor are associated with the development of osteosarcoma. Lenvatinib is a potent multiple receptor tyrosine kinase inhibitor that selectively inhibits VEGF receptors.