XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma
- Conditions
- Metastatic LeiomyosarcomaUnresectable Leiomyosarcoma
- Registration Number
- NCT06571734
- Lead Sponsor
- Northwestern University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria:<br><br> - Patients must have histologically confirmed leiomyosarcoma that has been clinically<br> determined to be metastatic or unresectable. Pathology must have been reviewed at a<br> National Comprehensive Cancer Network (NCCN) designated cancer center such as<br> Northwestern University's Lurie Cancer Center<br><br> - Patients must have undergone > 2 prior lines of antineoplastic treatment, but no<br> more than 2 lines of treatment can be a tyrosine kinase inhibitor<br><br> - Patients must have measurable disease according to Response Evaluation Criteria in<br> Solid Tumors (RECIST) version (v)1.1<br><br> - Patients must be aged = 18 years on day of signing any informed consent documents<br><br> - Patients must exhibit a performance status of 0 or 1 on the Eastern Cooperative<br> Oncology Group (ECOG) Performance Scale or > 70% on the Karnofsky Scale<br><br> - Leukocytes (white blood cells [WBC]) = 3,000/mcL<br><br> - Absolute neutrophil count (ANC) = 1,500/mcL (without granulocyte colony-stimulating<br> factor support within 14 days of screening sample collection)<br><br> - Hemoglobin (Hgb) = 9 g/dL without transfusion within 14 days of screening laboratory<br> sample collection<br><br> - Platelets (PLT) = 100,000/mm^3 (> 100 GI/L) without transfusion within 14 days of<br> screening laboratory sample collection<br><br> - International normalized ratio (INR) = 1.5 and activated partial thromboplastin time<br> (aPTT) = 1.2 x upper limit of normal (ULN)<br><br> - Total bilirubin = 1.5 x institutional upper limit of normal ULN; for patients with<br> Gilbert's disease, total bilirubin = 3 x ULN<br><br> - Alanine aminotransferase (AST) = 3 x institutional ULN<br><br> - Aspartate aminotransferase (ALT) = 3 x institutional ULN<br><br> - Alkaline phosphatase (ALP) = 3 x institutional ULN; for patients with documented<br> bone metastasis, ALP = 5 x ULN<br><br> - Serum creatinine = 1.5 x institutional ULN OR calculated creatinine clearance = 40<br> mL/min ( = 0.67 mL/sec) using the Cockcroft-Gault equation<br><br> - Creatinine clearance = 40mL/min<br><br> - Urine protein-to-creatinine ratio (UPCR) = 1 mg/mg ( = 113.12 mg/mmol)<br><br> - INR (or prothrombin time [PT] or partial thromboplastin time [PTT]; one will be<br> used) = 1.5<br><br> - aPTT = 1.5 x ULN (unless patient is receiving anticoagulant therapy as long as PT or<br> PTT is within therapeutic range of intended use of anticoagulants [within 10 days of<br> treatment initiation])<br><br> - Patient of child-bearing potential (POCBP) and any of their partners with<br> sperm-producing reproductive capability must agree to use a highly effective method<br> of contraception throughout the course of the study and for 186 days after the last<br> dose of treatment. Additional contraceptive method, such as a barrier method (e.g.,<br> condom) is also required<br><br> - Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on<br> this protocol must agree to use adequate contraception (hormonal or barrier method<br> of birth control; abstinence), with partners of childbearing potential from time of<br> informed consent, for the duration of study participation, and for 120 days<br> following completion of therapy<br><br> - Patients must have ejection fraction > 50% by either MUGA scan or echocardiogram<br><br> - Patients must be capable of understanding and complying with the protocol<br> requirements<br><br> - Patients must have the ability to understand and the willingness to sign a written<br> informed consent document<br><br>Exclusion Criteria:<br><br> - Patients who have received previous treatment with XL092<br><br> - Patients who have received any type of small-molecule kinase inhibitor (including an<br> investigational kinase inhibitor) within 14 days prior to study day 1 treatment<br><br> - Patients who have received > 2 prior tyrosine kinase inhibitor therapies<br><br> - Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior<br> to study day 1 unless they have recovered from their prior therapy (toxicity and/or<br> complications) such that they now meet all other eligibility criteria<br><br> - Patients who have received radiation therapy for bone metastasis within 14 days<br> prior to registration<br><br> - Patients who have undergone systemic treatment with radionuclides within 6 weeks (42<br> days) before first dose of study treatment<br><br> - Patients with clinically relevant complications from prior radiation therapy<br> requiring ongoing therapy, per the opinion of the treating investigator enrolling<br> the patient<br><br> - Patients with a known prior or concurrent malignancy that is progressing or requires<br> active treatment within 2 years of first dose of study treatment. Note: The<br> following exceptions may be made:<br><br> - For patients with malignancies like basal cell carcinoma of the skin or<br> squamous cell carcinoma of the skin that has undergone potentially curative<br> therapy or in situ cervical cancer; or superficial skin cancers, localized<br> low-grade tumors deemed cured and not treated with systemic therapy, and<br> incidentally diagnosed prostate cancer if assessed as stage = T2N0M0 and<br> Gleason score = 6<br><br> - For patients with a prior or concurrent malignancy whose natural history or<br> treatment does not have the potential to interfere with the safety or efficacy<br> assessment of the investigational regimen<br><br> - Patients with known brain metastases or cranial epidural disease unless adequately<br> treated with radiotherapy and/or surgery (including radiosurgery) and stable for at<br> least 4 weeks prior to first dose of study treatment. Note: Patients with an<br> incidental finding of an isolated brain lesion < 1 cm in diameter may be eligible<br> after principal investigator approval if the lesion is radiographically stable for 4<br> weeks before first dose and does not require treatment per Investigator judgement.<br> Note: Eligible patients must be neurologically asymptomatic and without<br> corticosteroid treatment at the time of first dose of study treatment<br><br> - Patients who are on concomitant anticoagulation therapy with oral anticoagulants<br> (e.g., warfarin or direct thrombin and factor Xa inhibitors) and platelet inhibitors<br> (e.g., clopidogrel). Note: Allowed anticoagulants are low-dose aspirin for<br> cardioprotection (per local applicable guidelines) and low molecular weight heparins<br> (LMWH). Therapeutic doses of LMWH are not permitted in patients with brain<br> metastases. Note: Patients must have discontinued oral anticoagulants within 3 days<br> or 5 half-lives prior to first study treatment, whichever is longer<br><br> - Patients who are taking any complementary medications (e.g., herbal supplements or<br> traditional Chinese medicines) to treat the disease under study within 2 weeks (14<br> days) prior to registration. Note: taking complementary medications to treat<br> symptoms of the cancer is allowed<br><br> - The patient has uncontrolled, significant intercurrent or recent illness including,<br> but not limited to, the following conditions:<br><br> - Cardiovascular disorders:<br><br> - Congestive heart failure New York Heart Association class 3 or 4, unstable<br> angina pectoris, serious cardiac arrhythmias (e.g., ventricular flutter,<br> ventricular fibrillation, Torsades de pointes)<br><br>
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method Median PFS;Overall survival (OS);Overall response rate (ORR);Duration of response (DOR);Incidence of adverse events (AEs)