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NCT03449901 · ClinicalTrials.gov registry record · Phase 2
ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma, Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer
A Phase 2 study of Soft Tissue Sarcoma, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 4
- Study locations
NCT03449901: Completed Phase 2 study of Soft Tissue Sarcoma, sponsored by Washington University School of Medicine.
NCT03449901 is a Phase 2 study of Soft Tissue Sarcoma that has completed, run by Washington University School of Medicine. The registered enrollment target is 98 participants, above the 77-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (27% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03449901, a Phase 2 study of Soft Tissue Sarcoma, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 4
- Study locations
Study Summary
The investigators have recently demonstrated that argininosuccinate synthase 1 (ASS1) expression is silenced in 88% of all sarcomas (n=708), and that this loss is associated with a decreased overall survival. Using the extracellular arginine depleting enzyme PEGylated arginine deiminase (ADI-PEG20), an extracellular arginine depleting enzyme, the investigators demonstrated ADI-PEG20 induces a prosurvival metabolic reprogramming in ASS1-deficient sarcomas that redirects glucose into the serine/folate pathway directing the carbons from glucose into pyrimidine biosynthesis, thus sensitizing cells to death by the pyrimidine antimetabolite gemcitabine by using metabolomics. The synthetic lethality was increased by the addition of docetaxel. Therefore a phase II clinical trial of ADI with gemcitabine and docetaxel, a standard second line therapy for soft tissue sarcoma will be conducted to determine if the clinical benefit rate of gemcitabine and docetaxel is improved by the metabolic changes induced by ADI-PEG20. Recently published data shows that priming ASS1-deficient tumors with ADI-PEG 20 and docetaxel improves the effect of gemcitabine. Therefore, a cohort of patients consisting of ten patients diagnosed with either osteosarcoma or Ewing's sarcoma (ideally five of each), and five patients diagnosed with small cell lung cancer will be included as an exploratory cohort. Enrollment to Cohort 2 will occur concurrently with Cohort 1.
Primary Outcome
* PFS: defined as time on study to time patients progressed on the drug combination or death or latest follow-up if progression/death is not observed yet * Progressive disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Gemcitabine
- PROCEDURE Tumor biopsy
- PROCEDURE Research blood draw
- DRUG pegylated arginine deiminase
Study Locations (4)
California
- Stanford Medicine - Palo Alto
- Sarcoma Oncology Center - Santa Monica
Missouri
- Washington University School of Medicine - St Louis
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2022-07-08 |
| Phase | Phase 2 |
What the finished NCT03449901 record still lists
NCT03449901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 77-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (27% higher).
The record links to 1 condition, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT03449901 reports a single indexed study location in California, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT03449901 about?
NCT03449901 is a clinical study titled "ADI-PEG 20 in Combination With Gemcitabine and Docetaxel for the Treatment of Soft Tissue Sarcoma, Osteosarcoma, Ewing's Sarcoma, and Small Cell Lung Cancer". The investigators have recently demonstrated that argininosuccinate synthase 1 (ASS1) expression is silenced in 88% of all sarcomas (n=708), and that this loss is associated with a decreased overall survival. Using the extracellular arginine depleting enzyme PEGylated arginine deiminase (ADI-PEG20),...
What is the current status of trial NCT03449901?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2018-05-09. Estimated completion is 2022-07-08.
What conditions does trial NCT03449901 study?
This clinical trial studies the following conditions: Soft Tissue Sarcoma.
What interventions are being tested in trial NCT03449901?
The interventions under investigation include: Docetaxel (DRUG), Gemcitabine (DRUG), Tumor biopsy (PROCEDURE), Research blood draw (PROCEDURE), pegylated arginine deiminase (DRUG).
Who is sponsoring clinical trial NCT03449901?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03449901 being conducted?
This trial has 4 study locations across California, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03449901's enrollment target sits among peer trials
98 10th of 55 higher than 45 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
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