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XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma

RecruitingPhase 2Ages 18 Years - anyAllNorthwestern University
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria For Cohort 1 - Leiomyosarcoma: * 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 at least 2 or more lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI). Inclusion Criteria For Cohort 2 - Bone Sarcoma: * Patients must have histologically confirmed diagnosis of metastatic or unresectable bone sarcoma. 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 at least 1 or more prior lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI). Inclusion Criteria For Cohort 3 - Translocation-associated Soft Tissue Sarcoma: * Patients must have histologically confirmed diagnosis of metastatic or unresectable translocation-associated soft tissue sarcoma (TAS). 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 at least 1 or more prior lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI). Inclusion Criteria for All Cohorts/Sarcoma Types * 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. * Absolute neutrophil count (ANC) ≥ 1,500/mcL (without granulocyte colony-stimulating factor support within 21 days of screening sample collection) * Hemoglobin (Hgb) ≥ 9 g/dL without transfusion within 21 days of screening laboratory sample collection * Platelets (PLT) ≥ 100,000/mm\^3 (\> 100 GI/L) without transfusion within 21 days of screening laboratory sample collection * International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN) * Total bilirubin ≤ 1.5 x institutional upper limit of normal ULN; for patients with Gilbert's disease, total bilirubin ≤ 3 x ULN * Alanine aminotransferase (AST) ≤ 3 x institutional ULN * Aspartate aminotransferase (ALT) ≤ 3 x institutional ULN * Alkaline phosphatase (ALP) ≤ 3 x institutional ULN; for patients with documented bone metastasis, ALP ≤ 5 x ULN * Serum creatinine ≤ 1.5 x institutional ULN OR calculated creatinine clearance ≥ 40 mL/min ( ≥ 0.67 mL/sec) using the Cockcroft-Gault equation * Creatinine clearance ≥ 40mL/min * Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg ( ≤ 113.12 mg/mmol) * Patient of child-bearing potential (POCBP) and any of their partners with sperm-producing reproductive capability must agree to use a highly effective method of contraception throughout the course of the study and for 186 days after the last dose of treatment. Additional contraceptive method, such as a barrier method (e.g., condom) is also required * Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), with partners of childbearing potential from time of informed consent, for the duration of study participation, and for 96 days following completion of therapy * Patients must have ejection fraction \> 50% by either MUGA scan or echocardiogram. * Patients must be capable of understanding and complying with the protocol requirements. * Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have received previous treatment with XL092. * Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study day 1 treatment. * Patients who have received \> 2 prior tyrosine kinase inhibitor therapies as anticancer treatments. * Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior to start of study treatment unless they have recovered from their prior therapy (toxicity and/or complications) such that they now meet all other eligibility criteria * Patients who have received radiation therapy for bone metastasis within 14 days prior to registration * Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment * Patients with clinically relevant complications from prior radiation therapy requiring ongoing therapy, per the opinion of the treating investigator enrolling the patient. * Patients with a known prior or concurrent malignancy that is progressing or requires active treatment within 2 years of first dose of study treatment. Note: The following exceptions may be made: * For patients with malignancies like basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; or superficial skin cancers, localized low-grade tumors deemed cured and not treated with systemic therapy, and incidentally diagnosed prostate cancer if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6. * For patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen. * Patients with known brain metastases or cranial epidural disease unless adequately treated with radiothe
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What it tests

  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography
  • Multigated Acquisition Scan
  • Zanzalintinib
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Where

1 site
Northwestern University
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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