NCT05712694

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Polaris Group · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trial that will compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-11-29
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2023-02-03
• Last updated: 2025-07-17

Locations

30 sites across 3 countries: United States, Canada, Taiwan

Regulatory

• FDA-regulated drug study