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NCT05712694 · ClinicalTrials.gov registry record · Phase 3
Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)
A Phase 3 study of Soft Tissue Sarcoma, sponsored by Polaris Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT05712694: Recruiting Phase 3 study of Soft Tissue Sarcoma, sponsored by Polaris Group.
NCT05712694 is a Phase 3 study of Soft Tissue Sarcoma that is actively recruiting participants, run by Polaris Group. The registered enrollment target is 300 participants, above the 73-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (311% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05712694, a Phase 3 study of Soft Tissue Sarcoma, is actively recruiting participants, sponsored by Polaris Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
Primary Outcome
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)
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ADI PEG20
Study Locations (20)
California
- USC Norris comprehensive cancer center - Los Angeles
- Stanford University Medical Centre - Palo Alto
- UCSF - San Francisco
- UCLA - Santa Monica
Florida
- Mayo Clinic Florida - Jacksonville
- University of Miami/ Sylvester Comprehensive Cancer Center - Miami
- Moffitt Cancer Center - Tampa
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- Cleveland Clinic - Cleveland
Arizona
- Mayo Clinic Arizona - Phoenix
Colorado
- University of Colorado Cancer Center/ CU Anschutz Medical Campus - Aurora
Illinois
- Northwestern - Chicago
Indiana
- Indiana University - Indianapolis
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-11-29 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 3 |
What NCT05712694 shows while recruiting
NCT05712694 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (311% higher).
The record links to 1 condition, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05712694 names 20 study sites across 14 states, led by California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT05712694 about?
NCT05712694 is a clinical study titled "Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)". To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.
What is the current status of trial NCT05712694?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2023-11-29. Estimated completion is 2027-12-30.
What conditions does trial NCT05712694 study?
This clinical trial studies the following conditions: Soft Tissue Sarcoma.
What interventions are being tested in trial NCT05712694?
The interventions under investigation include: Placebo (OTHER), ADI PEG20 (DRUG).
Who is sponsoring clinical trial NCT05712694?
This trial is sponsored by Polaris Group, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05712694 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Soft Tissue Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05712694's enrollment target sits among peer trials
300 5th of 55 higher than 51 of 55 other Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Soft Tissue Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase III Trial of Anlotinib, Catequentinib in Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma, Synovial Sarcoma (APROMISS)
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-
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