Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
← catalyst calendarSponsored by Polaris Group (industry) · PII — their whole pipeline →.
Phase
Phase 3
Status
Terminated
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
218actual
Sites
30
Countries
Canada, Taiwan, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Lack of Efficacy, no safety concern.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-11-29 | actual | When the study began enrolling |
| Primary completion | 2026-05-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-25 | actual | The whole study's end, after follow-up |
| First posted | 2023-02-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Soft Tissue Sarcoma
Interventions
- Drug: ADI PEG20 — also filed as Pegargiminase
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFPrimary End Point of PFS
measured Subjects will receive triplet combination treatment followed by weekly monotherapy ADI-PEG 20 or PBO (Each cycle is 21 days). Subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).
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