NCT05712694Phase 3Terminated

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-05-25Actual

Enrollment · participants218Actual

Source updated2026-06-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-06-25 · 5 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~300 participants (planned)~~

+ After

218 participants (actual)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~30 Dec 2027~~

+ After

25 May 2026

Recruitment status changed

− Before

~~Recruiting~~

+ After

Terminated

Check registry source

Study details

Conditions studied

Soft Tissue Sarcoma

Treatments or interventions studied

ADI PEG20DrugAlso known as Pegargiminase

Primary outcomes · main study measures

Read the study measures

measure: Primary End Point of PFS; description: The primary objective is to compare the primary endpoint of PFS in subjects treated with the arginine degrading enzyme ADI-PEG 20 plus Gem and Doc (ADIGemDoc) or PBO plus Gem and Doc (PBOGemDoc) in the 2nd or 3rd line setting using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by blinded independent central review committee (BICR); timeFrame: 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).

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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