Phase 2 Study of Zanzalintinib for Advanced Bone Sarcomas (ZAMBONE)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07193550

Provider View

This clinical trial is testing the effectiveness of the drug zanzalintinib in treating advanced or metastatic bone sarcomas. The study aims to see how well the drug works in stopping the cancer from growing and to evaluate its safety.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well the drug zanzalintinib works in patients with advanced or metastatic bone sarcomas. The study will look at how long patients can go without their cancer getting worse and assess the safety of the drug. Researchers will also study certain markers in the cancer cells to see if they relate to how well the treatment works.

Description

This study is divided into different groups based on the type of bone sarcoma: osteosarcoma, Ewing sarcoma, chondrosarcoma, and other bone sarcomas. The main goal is to see how long patients can go without their cancer getting worse after starting treatment with zanzalintinib. The study will also measure how many patients' tumors shrink and how long they live after treatment. Safety and side effects of the drug will be closely monitored.

Researchers will also explore if certain markers in the cancer cells can predict how well the treatment works. Patients will need to provide tumor samples before and during treatment for this analysis.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with advanced or metastatic bone sarcoma that cannot be surgically removed.
  • Types of bone sarcoma include osteosarcoma, Ewing sarcoma, chondrosarcoma, and other primary bone sarcomas.
  • Must have tried at least one previous treatment for advanced cancer unless no standard treatment exists.
  • Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
  • Must have measurable cancer that can be tracked using scans.
  • Must have adequate blood counts and organ function as determined by specific tests.
  • Women of childbearing potential must not be pregnant and must agree to use effective birth control during the study.
  • Men must agree not to donate sperm during the study and for a period after the last dose of the drug.
  • Must be willing to sign a consent form and participate in related studies for sample collection.

Exclusion Criteria

  • Previous treatment with zanzalintinib.
  • Have a different type of cancer that has spread to the bones.
  • Have allergies to the study drug or similar medications.
  • Have untreated brain metastases or other serious medical conditions.
  • Have had recent heart problems or uncontrolled high blood pressure.
  • Have active infections or other serious health issues that could interfere with the study.
  • Are pregnant or breastfeeding.
  • Are unable to swallow pills or have certain dietary restrictions.
  • Are taking certain medications that could interfere with the study drug.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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