Study on ADI-PEG 20 or Placebo with Gemcitabine and Docetaxel for Previously Treated Leiomyosarcoma Patients

Sponsor: Polaris Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05712694

Provider View

This clinical trial is testing the effectiveness and safety of a new treatment combination for patients with advanced or metastatic leiomyosarcoma (LMS) who have already been treated with a type of chemotherapy called anthracycline.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness and safety of a new treatment combination, ADI-PEG 20 or a placebo with gemcitabine and docetaxel, in patients with advanced or metastatic leiomyosarcoma (LMS) who have previously received anthracycline treatment. This is a global study involving multiple centers, where participants will be randomly assigned to receive either the new treatment or a placebo, without knowing which one they are receiving.

Description

This study is a phase 3 trial conducted across various locations worldwide. It is designed to evaluate the safety and effectiveness of a new treatment combination for patients with advanced or metastatic leiomyosarcoma (LMS) who have already been treated with anthracycline chemotherapy. Participants will be randomly assigned to receive either ADI-PEG 20 or a placebo, along with gemcitabine and docetaxel. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. The goal is to determine if this new combination can improve outcomes for patients with LMS.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with grade 2 or 3 leiomyosarcoma (LMS) that would typically be treated with gemcitabine or gemcitabine and docetaxel.
  • Must know the subtype of LMS: uterine or non-uterine.
  • Have measurable disease that can be accurately measured by scans or physical exams.
  • Previously treated with up to two chemotherapy regimens, including at least one with doxorubicin.
  • Previous treatment with gemcitabine or docetaxel over a year ago is allowed.
  • Aged 18 years or older.
  • Good overall health with an ECOG performance status of less than 1.
  • Meet specific blood count and organ function criteria.
  • Agree to use effective contraception during the study and for a specified period after treatment.
  • Able to understand and willing to sign the informed consent form.
  • Not participating in other investigational drug studies.

Exclusion Criteria

  • Have a history of another primary cancer, except for certain treated skin or cervical cancers.
  • Currently receiving other investigational treatments.
  • Previously treated with ADI-PEG 20, gemcitabine, or docetaxel, unless it was over a year ago in a specific setting.
  • Have known brain metastases.
  • Have allergies to similar compounds used in the study.
  • Have uncontrolled illnesses or conditions that would interfere with the study.
  • Have a history of seizures not related to cancer.
  • Have significant nerve damage (neuropathy) of grade 2 or higher.
  • Are pregnant or breastfeeding.
  • Have HIV and are on combination antiretroviral therapy.

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