Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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.
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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02097875