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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01260779




Registration number
NCT01260779
Ethics application status
Date submitted
13/12/2010
Date registered
15/12/2010
Date last updated
11/07/2016

Titles & IDs
Public title
Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors
Scientific title
Open Label Expanded Access for Investigational Use of PV-10 in Patients Who Are Not Eligible for an Existing PV-10 Clinical Trial, for Whom There is no Alternative Therapy, and Whom May Benefit From PV-10 Administration
Secondary ID [1] 0 0
PV-10-EA-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory 0 0
Approved Alternative Therapy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - PV-10 (10% rose bengal disodium)

Treatment: Drugs: PV-10 (10% rose bengal disodium)
Intralesional injection for chemoablation of cutaneous or subcutaneous lesions
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
1. Age 18 years or older, male or female.

2. Histologically or cytologically confirmed cancer where there is no comparable or
satisfactory approved alternative therapy specific to cutaneous or subcutaneous
tumors.

3. Performance Status: ECOG 0-2.

4. Life Expectancy: At least 6 months.

5. Blood Chemistry:

- Creatinine = 3 times the upper limit of normal (ULN).

- Total bilirubin = 3 times the upper limit of normal (ULN).

- AST/ALT/ALP = 5 times the upper limit of normal (ULN).

6. Thyroid Function

- Total T3 or free T3 (serum triiodothyronine), total T4 or free T4 (serum
thyroxine) and THS (serum thyrotropin) = grade 2 abnormality.

7. Renal Function

- Subjects must have adequate renal function in the opinion of the Investigator
with no clinically significant renal impairment or uncontrolled renal disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Cancer patients who are eligible for an existing PV-10 clinical trial.

2. Certain photosensitizing agents within 5 half-lives prior to PV-10 administration.

3. Concurrent or Intercurrent Illness:

- Subjects with uncontrolled diabetes or extremity complications due to diabetes.

- Subjects with severe peripheral vascular disease.

- Subjects with significant concurrent or intercurrent illness, psychiatric
disorders, or alcohol or chemical dependence that would, in the opinion of the
Investigator, compromise their safety or compliance or interfere with
interpretation of study results.

- Subjects with uncontrolled thyroid disease, goiter, partial thyroidectomy,
radioiodine- or surgically-treated Graves' hyperthyroidism or cystic fibrosis.

- Subjects with clinically significant acute or unstable cardiovascular, (stroke),
renal, gastrointestinal, pulmonary, immunological (with the exception of the
presence of hepatitis B virus (HBV), viral hepatitis, or cirrhosis), endocrine,
or central nervous system disorders.

4. Pregnancy:

- Female subjects who are pregnant or lactating.

- Female subjects who have positive serum ßHCG pregnancy test taken within 7 days
of PV-10 administration.

- Fertile subjects who are not using effective contraception.

5. Investigational Agents:

- Subjects who have received investigational agents within 4 weeks (or 5
half-lives) of study administration.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
No longer available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Melanoma Institute Australia - Sydney (North Sydney and Camperdown)
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hospital Cancer Centre - Adelaide
Recruitment postcode(s) [1] 0 0
- Sydney (North Sydney and Camperdown)
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kentucky
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Provectus Biopharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This compassionate use protocol provides expanded access for investigational use of PV-10 in
cancer patients who are not eligible for an existing PV-10 clinical trial, for whom there is
no comparable or satisfactory approved alternative therapy and whom, in the opinion of the
investigator, may benefit from PV-10 administration.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01260779
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01260779