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

NCT05712694 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-20

No results posted yet for this study

Summary

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

Conditions

  • Soft Tissue Sarcoma

Interventions

DRUG

ADI PEG20

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Polaris Group

    lead INDUSTRY

Principal Investigators

  • John S Bomalaski · Polaris Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-29
Primary Completion
2027-12-30
Completion
2027-12-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05712694 on ClinicalTrials.gov