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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/NCT02097875




Registration number
NCT02097875
Ethics application status
Date submitted
25/03/2014
Date registered
27/03/2014
Date last updated
21/04/2015

Titles & IDs
Public title
Safety Study of a Fluorescent Marker to Visualize Cancer Cells
Scientific title
A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer
Secondary ID [1] 0 0
ACTRN12614000115639
Secondary ID [2] 0 0
BB-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BLZ-100

Experimental: BLZ-100 - A single dose of BLZ-100 (1, 3, 6, 12 or 18 mg) will be administered by intravenous injection approximately 48 hours prior to planned excision of skin tumor.


Treatment: Drugs: BLZ-100
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events
Timepoint [1] 0 0
Within at least 1 week from baseline
Secondary outcome [1] 0 0
Change in concentration of BLZ-100 in the blood
Timepoint [1] 0 0
Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Secondary outcome [2] 0 0
Determination of a dose level for Phase 2 studies
Timepoint [2] 0 0
At end of study - approximately 14 months

Eligibility
Key inclusion criteria
- Male or female patients age = 18 years.

- Known or suspected non-metastatic basal cell or squamous cell carcinomas =10 mm
longest diameter or non-metastatic melanoma =6 mm longest diameter scheduled for
excision, without advanced disease.

- Written Informed Consent.

- Agree to the use of effective contraceptive from Baseline and for 30 days after
treatment if either male or female of child bearing potential.

- Available for and able to comply with study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women who are lactating/breastfeeding

- Women with a positive pregnancy test or who are planning to become pregnant during the
duration of the study.

- Life expectancy <6 months.

- Karnofsky Performance Status of =70%.

- The following laboratory abnormalities:

- Neutrophil count <1.5 x 10^9/L

- Platelets <75 x 10^9/L

- Haemoglobin <10 g/dL (may be determined following transfusion)

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper
limit of normal (ULN)

- Total bilirubin >2x upper limit of reference range (unless Gilbert's syndrome or
extrahepatic source as denoted by increased indirect bilirubin fraction)

- International Normalized Ratio (INR) >1.5

- Creatinine >1.5x ULN

- History of hypersensitivity or allergic reactions requiring corticosteroids,
epinephrine and/or hospitalization.

- Uncontrolled asthma or asthma requiring oral corticosteroids.

- Clinically significant chronic inflammatory skin conditions, including psoriasis,
atopic dermatitis and scleroderma, as determined by the investigator.

- Unstable angina, myocardial infarction, known or suspected transient ischemic events
or stroke within 24 weeks of Screening.

- Uncontrolled hypertension.

- QTc (corrected QT interval) prolongation >450 msec.

- Receipt of photosensitising drugs within 30 days of screening.

- Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or
hepatitis B virus (HBV).

- Any concurrent condition, including psychological and social situations, which, in the
opinion of the investigator, would impact adversely on the subject or the
interpretation of the study data.

- Known or suspected sensitivity to study product or excipients.

- Prior participation in this clinical trial (has received study product).

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Veracity Clinical Research Pty Ltd - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Blaze Bioscience Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Many types of cancer are primarily treated with surgery and patient survival is directly
related to the extent to which the tumor is able to be removed. It is often difficult for
surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have
spread from the original tumor site, resulting in incomplete removal of the tumor and reduced
patient survival. In addition, in some sites, such as the brain, it is critical to avoid
damage to normal tissue around the tumor to prevent adverse effects of surgery on function.
We hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize
the edges of the tumor and small groups of cancer cells that have spread to other sites in
real-time, as they operate.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02097875
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynda Spelman, MBBS FACD
Address 0 0
Veracity Clinical Research Pty Ltd
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/NCT02097875