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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 is a Phase 1 study that has completed, run by Ludwig Institute for Cancer Research. The registered enrollment target is 31 participants.
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.
Interventions
- DRUG ADI PEG 20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00520299
The ClinicalTrials.gov registry entry for NCT00520299 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ludwig Institute for Cancer Research, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ADI PEG 20 is the first listed.
NCT00520299 reports 0 study locations.
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.
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