RecruitingPhase 3NCT05712694

Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)

ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 Trial

Sponsor

Polaris Group

Enrollment

300 participants

Start Date

Nov 29, 2023

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma

Summary

To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ADI-PEG 20 — a drug that depletes arginine, an amino acid that some cancers depend on — combined with gemcitabine and docetaxel (standard chemotherapy) is more effective than chemotherapy alone for treating leiomyosarcoma, a type of soft tissue cancer. **You may be eligible if...** - You are over 18 with grade 2 or 3 leiomyosarcoma (either uterine or non-uterine) - Your cancer is measurable on imaging - You have received 1–2 prior treatment regimens, including at least one doxorubicin-based regimen - Your physical condition (ECOG 0 or 1) and organ function (blood counts, liver, kidneys) are within acceptable levels **You may NOT be eligible if...** - You have received more than 2 prior treatment regimens - You have known argininosuccinate synthetase 1 (ASS1) expression in your tumor (which would make the drug ineffective) - You have serious heart rhythm problems - You are pregnant or breastfeeding - You have uncontrolled gout or very high uric acid levels 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

DRUGADI PEG20

Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)

OTHERPlacebo

Treatment for advanced or metastatic uterine/non-uterine leiomyosarcoma (LMS)

Locations(31)

Mayo Clinic Arizona

Phoenix, Arizona, United States

USC Norris comprehensive cancer center

Los Angeles, California, United States

Stanford University Medical Centre

Palo Alto, California, United States

UCSF

San Francisco, California, United States

UCLA

Santa Monica, California, United States

University of Colorado Cancer Center/ CU Anschutz Medical Campus

Aurora, Colorado, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

University of Miami/ Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Mass General Brigham Cancer Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

Columbia University

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center/ The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

UPenn (Abramson Cancer Center, Pennsylvania Hospital)

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Medical College of Wisconsin/ Froedtert Hospital

Milwaukee, Wisconsin, United States

UHN - Princess Margaret Cancer Center (Ontario)

Toronto, Ontario, Canada

McGill University Health Centre (Quebec)

Montreal, Quebec, Canada

Chang Gung Medical Foundation Kaohsiung

Kaohsiung City, Niaosong District, Taiwan

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05712694

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