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NCT00521053 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma
A Phase 2 study, sponsored by Provectus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00521053: Completed Phase 2 study, sponsored by Provectus Pharmaceuticals.
NCT00521053 is a Phase 2 study that has completed, run by Provectus Pharmaceuticals. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00521053, a Phase 2 study, has completed, sponsored by Provectus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
The primary objective of this study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. This study will also include assessment of response in untreated bystander lesions following intralesional injection of PV-10 into targeted lesions. Additional objectives are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection.
Primary Outcome
Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (ORR) = %CR + %PR.
Interventions
- DRUG PV-10 (10% rose bengal disodium)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2007-09 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT00521053 record still lists
NCT00521053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which PV-10 (10% rose bengal disodium) is the first listed.
NCT00521053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00521053 about?
NCT00521053 is a clinical study titled "Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma". The primary objective of this study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. This study will also include assessment of response in untreated bystander lesions following intralesional injection of PV-10 into targeted lesions. ...
What is the current status of trial NCT00521053?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2007-09. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00521053?
The interventions under investigation include: PV-10 (10% rose bengal disodium) (DRUG).
Who is sponsoring clinical trial NCT00521053?
This trial is sponsored by Provectus Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00521053's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 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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