A Non-Randomized, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma
Northwestern University
Summary
This phase II trial tests how well zanzalintinib (XL092) works in treating patients with leiomyosarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Leiomyosarcomas are a type sarcoma that can occur in any location in the body, such as the uterus or in the abdomen. Current standard treatment for leiomyosarcoma only shows a progression-free survival of 4-6 months. XL092, a tyrosine kinase inhibitor, interferes with cell communication and growth and may prevent tumor growth. Giving XL092 may kill more tumor cells in patients with metastatic or unresectable leiomyosarcoma. The trial has now been expanded to treat additional sarcoma types that are sensitive to tyrosine kinase inhibitors (TKIs) such as translocation-associated soft tissue sarcoma (such as synovial sarcoma), and bone sarcoma (including osteosarcoma and Ewing sarcoma).
Description
PRIMARY OBJECTIVE: I. Evaluate 6-month progression-free survival (PFS) of patients with advanced leiomyosarcoma (LMS), bone sarcoma, or translocation-associated soft tissue sarcoma (TAS) who have been treated with zanzalintinib (XL092) monotherapy. SECONDARY OBJECTIVES: I. Evaluate median progression-free survival (PFS) in patients with advanced leiomyosarcoma (LMS), bone sarcoma, or translocation-associated soft tissue sarcoma (TAS) who have been treated with XL092 monotherapy. II. Determine overall survival (OS) in patients with advanced leiomyosarcoma (LMS), bone sarcoma, or translocati…