Study on XL092 (Zanzalintinib) for Treating Advanced or Inoperable Leiomyosarcoma

Sponsor: Northwestern University

Sponsor score: 0

ClinicalTrials ID:NCT06571734

Provider View

This clinical trial is testing a new drug, XL092 (Zanzalintinib), to see if it can help treat leiomyosarcoma, a type of cancer that has spread or cannot be removed by surgery. The study aims to find out if XL092 can stop the cancer from growing and improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring the effectiveness of a new drug called XL092 (Zanzalintinib) for treating leiomyosarcoma, a type of cancer that can occur in various parts of the body, like the uterus or abdomen. Leiomyosarcoma can be challenging to treat, especially when it spreads or cannot be surgically removed. Current treatments only keep the cancer from growing for about 4-6 months. XL092 is a type of medication that may help stop cancer cells from growing by interfering with their communication and growth. This study will see if XL092 can help kill more cancer cells in patients with advanced or inoperable leiomyosarcoma.

Description

The main goal of this study is to see if XL092 can keep the cancer from growing for at least 6 months in patients with advanced leiomyosarcoma. Researchers will also look at how long patients live without the cancer getting worse, the overall survival rate, how many patients respond to the treatment, and how long those responses last. They will also monitor any side effects of XL092.

Participants will take XL092 by mouth once a day for 14 days in each cycle, with cycles repeating every 14 days as long as the cancer does not progress and side effects are manageable. Patients will have heart tests and blood samples taken, and undergo CT scans during the study.

After finishing the treatment, patients will have follow-up visits 30 days later, then every 12 weeks for 2 years, and every 6 months for up to 5 years from the start of the study.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of leiomyosarcoma that has spread or cannot be removed by surgery.
  • Must have tried at least two previous cancer treatments, but no more than two treatments with a similar type of drug.
  • Must have measurable cancer according to specific medical criteria.
  • Must be 18 years or older.
  • Must be in good overall health, with a performance status score of 0 or 1.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must agree to use effective birth control during the study and for a specified time after the last dose of treatment.
  • Must have a heart function test showing an ejection fraction greater than 50%.
  • Must be able to understand and agree to the study requirements and sign a consent form.

Exclusion Criteria

  • Cannot have received XL092 before.
  • Cannot have taken certain similar drugs within 14 days before starting the study.
  • Cannot have had more than two previous treatments with similar drugs.
  • Cannot have had recent chemotherapy or radiation unless fully recovered.
  • Cannot have certain other cancers that require treatment or are progressing.
  • Cannot have untreated or unstable brain metastases.
  • Cannot be on certain blood thinners or complementary medicines.
  • Cannot have certain serious health conditions, like uncontrolled heart problems or recent strokes.
  • Cannot have significant bleeding issues or certain lung conditions.
  • Cannot be pregnant or breastfeeding.
  • Cannot have certain infections or be unable to swallow pills.
  • Cannot be participating in another clinical trial or have used an investigational device recently.
  • Cannot have any other condition that might make the study unsafe or difficult to complete.

Locations

FACILITYZIPCITYSTATE
Northwestern University60611ChicagoIllinois

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