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NCT00520299 · ClinicalTrials.gov registry record · Phase 1
Study of ADI-PEG 20 in Patients With Advanced Melanoma
A Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00520299: Completed Phase 1 study, sponsored by Ludwig Institute for Cancer Research.
NCT00520299 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00520299, a Phase 1 study, has completed, sponsored by Ludwig Institute for Cancer Research.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
This was a phase 1/2, open-label, dose-escalation study of arginine deiminase linked via succinimidyl succinate to polyethylene glycol of 20,000 molecular weight (ADI-PEG 20) in subjects with advanced melanoma. ADI-PEG 20 was administered intramuscularly (IM) at escalating doses weekly for 9 weeks (cycle 1) or 8 weeks (subsequent cycles). The primary objectives were to the establish the safety, tolerability, and clinical efficacy of ADI-PEG 20. Secondary objectives included evaluation of the metabolic activity by \[18F\]-fluorodeoxyglucose positron emission tomography (FDG PET), pharmacodynamics, correlation of immunogenicity with clinical response, and correlation of argininosuccinate synthetase (ASS) tumor expression with clinical response.
Primary Outcome
Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.
Interventions
- DRUG ADI PEG 20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
What the finished NCT00520299 record still lists
NCT00520299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which ADI PEG 20 is the first listed.
NCT00520299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00520299 about?
NCT00520299 is a clinical study titled "Study of ADI-PEG 20 in Patients With Advanced Melanoma". This was a phase 1/2, open-label, dose-escalation study of arginine deiminase linked via succinimidyl succinate to polyethylene glycol of 20,000 molecular weight (ADI-PEG 20) in subjects with advanced melanoma. ADI-PEG 20 was administered intramuscularly (IM) at escalating doses weekly for 9 weeks (...
What is the current status of trial NCT00520299?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2007-07. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00520299?
The interventions under investigation include: ADI PEG 20 (DRUG).
Who is sponsoring clinical trial NCT00520299?
This trial is sponsored by Ludwig Institute for Cancer Research, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00520299's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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