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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Soft Tissue Sarcoma

In brief

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

Key facts

Study ID

NCT05712694

Run by

Polaris Group

People needed

218

Starts

2023-11-29

Expected to finish

2026-05-25

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A subject will be eligible for study participation if he/she meets the following criteria:
• Histologically or cytologically confirmed, grade 2 or 3, LMS STS that would be standardly treated with Gem or GemDoc.
• Determination of LMS subtype: uterine or non-uterine.
• Measurable disease per RECIST 1.1 (Appendix A), defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.
• Previous treatment with up to 2 systemic regimens, including at least 1 systemic regimen containing doxorubicin.
• Treatment > one year ago in the adjuvant/neoadjuvant setting with Gem or Doc is allowed.
• Age >18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of < 1 at enrollment (Appendix B).
• Leukocytes ≥ 3,000/mcL.
• Absolute neutrophil count ≥ 1,500/mcL.
• Platelets ≥ 100,000/mcL.
• Hemoglobin ≥ 8.0 g/dL
• Total bilirubin ≤ 2 x ULN. (≤ 3 x ULN for potential subjects with Gilbert's Disease)
• AST(SGOT)/ALT(SGPT) ≤ 3 x ULN (or ≤ 5 x ULN if liver metastases are present)
• Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault equation).
• Serum uric acid ≤ 8 mg/dL (with or without medication control).
• QTc interval range from 350 to 450 ms for adult men and from 360 to 460 ms for adult women.
• Subjects and their partners must be asked to use appropriate contraception. They must agree to use 2 forms of contraception or agree to refrain from intercourse for the duration of the study and for 35 days after the last dose of ADI-PEG 20 or for at least 3 months (male subjects) or 6 months (female subjects) after treatment with gemcitabine, whichever is the longer duration.
• Ability to understand and willingness to sign the informed consent form.
• No concurrent investigational drug studies are allowed.

You may not qualify if…

• A subject will not be eligible for study participation if he/she meets any of the exclusion criteria:
• Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of current diagnosis.
• Currently receiving chemotherapy, immunotherapy, interferon, radiation therapy or other investigational agents. Note: Chemotherapy agent washout period is 5 half-lives prior to randomization. Radiation washout period is 7 days prior to randomization.
• Prior treatment with ADI-PEG 20, Gem or Doc. Patients treated > one year ago in the adjuvant/neoadjuvant setting with Gem or Doc are allowed to be enrolled.
• Prior pelvic radiation.
• Known brain metastases. Such patients must be excluded from this trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, Gem, Doc, polysorbate 80, pegylated compounds, or other agents used in this study.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• History of seizure disorder not related to underlying cancer.
• Grade 2 or higher neuropathy.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
• Known HIV-positivity. Because of the potential for pharmacokinetic interactions of antiretroviral therapy with the study treatment. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
• Currently receiving other immunosuppressive agents.
• Subjects under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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