RecruitingPhase 2NCT06571734

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

Enrollment

29 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called zanzalintinib (XL092) for people with a rare soft-tissue cancer called leiomyosarcoma that has spread or cannot be removed by surgery. Researchers want to see if this drug can help slow or stop the cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with leiomyosarcoma confirmed at a major cancer center - Your cancer has spread or cannot be surgically removed - You have had 1 prior treatment for your cancer (but no more than 2 prior treatments with a type of drug called a tyrosine kinase inhibitor) - Your heart is pumping well (ejection fraction above 50%) - Your blood counts and organ function (liver, kidneys) are within acceptable ranges **You may NOT be eligible if...** - You have already been treated with this drug (XL092) - You recently had chemotherapy or radiation (within the last 4 weeks) - You have serious heart problems, uncontrolled high blood pressure, or had a stroke or heart attack within the past year - You have brain metastases that are not stable - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography

Undergo ECHO

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

DRUGZanzalintinib

Given PO


Locations(1)

Northwestern University

Chicago, Illinois, United States

View Full Details on ClinicalTrials.gov

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NCT06571734


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