OncoMatch/Clinical Trials/NCT05712694
Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
Is NCT05712694 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies ADI PEG20 for soft tissue sarcoma.
Treatment: ADI PEG20 — To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Performance status
ECOG 0–0(Fully active)
Prior therapy
Must have received: anthracycline (doxorubicin)
Previous treatment with up to 2 systemic regimens, including at least 1 systemic regimen containing doxorubicin.
Cannot have received: ADI-PEG 20 (ADI-PEG 20)
Prior treatment with ADI-PEG 20
Cannot have received: cytotoxic chemotherapy (gemcitabine, docetaxel)
Exception: Patients treated > one year ago in the adjuvant/neoadjuvant setting with Gem or Doc are allowed to be enrolled.
Prior treatment with ... Gem or Doc. Patients treated > one year ago in the adjuvant/neoadjuvant setting with Gem or Doc are allowed to be enrolled.
Cannot have received: radiation therapy
Exception: adjuvant/neoadjuvant radiation > 1 year ago allowed; prior pelvic radiation excluded
Prior pelvic radiation.
Lab requirements
Blood counts
Leukocytes ≥ 3,000/mcL; Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin ≥ 8.0 g/dL
Kidney function
Creatinine clearance ≥ 60 mL/min (by Cockcroft-Gault equation)
Liver function
Total bilirubin ≤ 2 x ULN (≤ 3 x ULN for Gilbert's Disease); AST(SGOT)/ALT(SGPT) ≤ 3 x ULN (or ≤ 5 x ULN if liver metastases are present)
Cardiac function
QTc interval range from 350 to 450 ms for adult men and from 360 to 460 ms for adult women
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Arizona · Phoenix, Arizona
- USC Norris comprehensive cancer center · Los Angeles, California
- Stanford University Medical Centre · Palo Alto, California
- UCSF · San Francisco, California
- UCLA · Santa Monica, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify