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NCT00450372 · ClinicalTrials.gov registry record · Phase 2
Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
A Phase 2 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT00450372: Completed Phase 2 study, sponsored by University of Miami.
NCT00450372 is a Phase 2 study that has completed, run by University of Miami. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00450372, a Phase 2 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an amino acid needed for cell growth. PURPOSE: This phase II trial is studying how well pegylated arginine deiminase works in treating patients with metastatic melanoma that cannot be removed by surgery.
Primary Outcome
Response rate is defined as a partial response, PR, and complete response, CR, lasting for at least 30 days per RECIST criteria, v. 1.0. Complete response will be defined as disappearance of all target lesions. Partial response will be defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference the baseline sum of LD
Interventions
- BIOLOGICAL ADI-PEG-20
- OTHER Pharmacology Studies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2004-06 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00450372 record still lists
NCT00450372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which ADI-PEG-20 is the first listed.
NCT00450372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00450372 about?
NCT00450372 is a clinical study titled "Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery". RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an amino acid needed for cell growth. PURPOSE: This phase II trial is studying how well pegylated arginine deiminase works in treating patients with metastatic melanoma that cannot be removed by surgery.
What is the current status of trial NCT00450372?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2004-06. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00450372?
The interventions under investigation include: ADI-PEG-20 (BIOLOGICAL), Pharmacology Studies (OTHER).
Who is sponsoring clinical trial NCT00450372?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00450372's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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