CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
PV-10 (10% rose bengal disodium)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00521053
NCT00521053Phase 2Completed
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A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma

Provectus Pharmaceuticals·interventional·Posted Aug 27, 2007·Updated Aug 25, 2014

In Brief

A Phase 2 clinical trial evaluating PV-10 (10% rose bengal disodium) for Melanoma. Completed, enrolled 80 participants across 7 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesAustralia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2007
Enrollment StartSep 1, 2007
Primary CompletionMay 1, 2010
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.8 years ago

Interventions

PV-10 (10% rose bengal disodium)drug

Intralesional injection for chemoablation