A Phase 1 Study to Assess the Safety, Tolerability and Effectiveness of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver in the Reduction of Biochemical Markers and Symptoms Caused by Secretory Products
Sponsor study identifier
interventional
12
1 country
1
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 1, 2021
Actual (reported)Study Completion
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is intended to determine the safety, tolerability and reduction of biochemical markers (Chromogranin A or, if deemed appropriate, 5-hydroxyindoleaceticacid) and troublesome symptoms (particularly diarrhea and flushing) of intralesional injection of PV-10 in subjects with NET metastatic to the liver that are not amenable to resection or other potentially curative therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 23, 2016
Actual (reported)February 26, 2016
Actual (reported)July 2016
Date type not reportedThis date has not been verified as actual or estimated.
September 1, 2021
Actual (reported)September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of Participants with Adverse Events
Incidence of Systemic and Locoregional Adverse Events will be Coded and Tabulated
28 days
Objective Response Rate (ORR)
6 months
Target Lesion Somatostatin Receptor (SSTR) Expression
6 months
Change in Neuroendocrine Tumor Biomarkers
6 months
Reduction in Major Symptoms
6 months
Reduction in Other Symptoms
6 months
Intralesional rose bengal disodium (PV-10) to one or more neuroendocrine tumor metastases to the liver
Percutaneous intralesional injection to NET tumor
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Price T, Depauw L, Cehic G, Wachter E, Sebben R, Reid J, Neuhaus S, Alawawdeh A, Kirkwood ID, Solanki R, McGregor M, Leopardi L, Rodrigues D, Maddern G. A phase 1 study to assess the safety, tolerability and effectiveness of PV-10 (Rose Bengal Sodium) in neuroendocrine tumours metastatic to the liver. Br J Cancer. 2025 Jun;132(10):888-896. doi: 10.1038/s41416-025-02976-9. Epub 2025 Mar 26.
Eric Wachter, Ph.D.
Provectus Biopharmaceuticals, Inc.
12 participants (actual enrollment reported by the registry).
First Submitted
February 23, 2016
First Posted
February 26, 2016
Study Start
July 2016
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 1, 2021
Actual (reported)Study Completion
September 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 8, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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