drugset / Trial / NCT05712694

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

NCT05712694

Phase 3 Terminated 218 enrolled Polaris Group
RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start
2023-11-29
Primary completion
2026-05-25
Completion
2026-05-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegargiminase Protein / enzyme biologic 36 mg/m2

Indications