A Single-Arm, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma
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.
Description
PRIMARY OBJECTIVE: I. Evaluate 6-month progression-free survival (PFS) of patients with advanced leiomyosarcoma (LMS) who have been treated with zanzalintinib (XL092) monotherapy. SECONDARY OBJECTIVES: I. Evaluate median progression-free survival (PFS) in patients with advanced LMS who have been treated with XL092 monotherapy. II. Determine overall survival (OS) in patients with advanced LMS who have been treated with XL092 monotherapy. III. Determine overall response rate (ORR) in patients with advanced LMS who have been treated with XL092 monotherapy. IV. Assess duration of response (D…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically confirmed leiomyosarcoma that has been clinically determined to be metastatic or unresectable. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as Northwestern University's Lurie Cancer Center * Patients must have undergone 1 prior line of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor * Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 * Patients must b…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- ProcedureEchocardiography
Undergo ECHO
- ProcedureMultigated Acquisition Scan
Undergo MUGA
- DrugZanzalintinib
Given PO
Location
- Northwestern UniversityChicago, Illinois