AOST1321, Phase 2 Study of Denosumab (IND#127430, NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma
Study ID: STU 112015-037
This is a prospective single arm, open-label, phase ii trial of RanKL antibody, denosumab, in recurrent osteosarcoma with osteosarcoma-specific cohorts and osteosarcoma-specific endpoints. Patients will enroll on either the measurable disease cohort or the completely resected disease cohort. all patients will receive subcutaneous denosumab every 4 weeks with a loading dose on Days 8 and 15 of Cycle 1. endpoints for the cohort with measurable disease (Cohort 1) are the disease control rate at 4 months as compared to historical CoG experience or objective response rate. The endpoint for the fully resected cohort (Cohort 2) is the disease control rate at 12 months as compared to historical CoG experience. Secondary objectives include pharmacokinetics, pharmacodynamics and tolerability of denosumab in patients with recurrent osteosarcoma. Biological markers, particularly RanK and RanKL expression will be explored.