XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma
A Single-Arm, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma
Sponsor: Northwestern University + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-free survival (PFS)
Time frame: Up to 6 months
Secondary Endpoints
Median PFS
Overall survival (OS)
Overall response rate (ORR)
Eligibility Criteria
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 be aged ≥ 18 years on day of signing any informed consent documents * Patients must exhibit a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or \> 70% on the Karnofsky Scale * Leukocytes (white blood cells \[WBC\]) ≥ 3,000/mcL * Absolute neutrophil count (ANC) ≥ 1,500/mcL (without granulocyte colony-stimulating factor support within 14 days of screen…
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Expert commentary on why this trial matters and what to watch for.
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