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Trial registered on ANZCTR


Registration number
ACTRN12614000115639
Ethics application status
Approved
Date submitted
16/12/2013
Date registered
29/01/2014
Date last updated
19/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A safety study of a fluorescent marker to visualise 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] 283775 0
NCT02097875
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin cancer 290751 0
Condition category
Condition code
Cancer 291110 291110 0 0
Non melanoma skin cancer
Cancer 294409 294409 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BLZ-100, a targeted fluorescent molecule that belongs to a class of products known as Tumor Paint (Trademark) bioconjugates designed to illuminate cancer foci to facilitate surgical resection. BLZ-100 will be administered as a single, intravenous dose approximately 48 hours before scheduled excision of skin cancer lesions. The study consists of two parts: a dose escalation and a dose expansion. In the dose escalation part of the study, the dose of BLZ-100 will be increased in cohorts of subjects until either the highest pre-specified dose level is reached or unacceptable side effects are noted. The planned dose cohorts are 1, 3, 6, 12 and 18 mg BLZ-100. Escalation to a higher dose cohort will proceed when the previous dose has been found to be reasonably tolerated based on available safety data for all subjects enrolled in the cohort. Upon completion of the dose escalation, a dose level shown to be well-tolerated will be selected to enrol subjects in the dose expansion part of the study.
Intervention code [1] 288461 0
Treatment: Drugs
Intervention code [2] 288462 0
Treatment: Surgery
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291097 0
Safety as assessed by vital signs, adverse events (AEs), physical examinations and laboratory safety parameters. The possible side effects of BLZ-100 in humans are unknown. Data from animal studies suggests possible adverse events could include allergic reactions, decreased activity/slowed movements or sleepiness.
Timepoint [1] 291097 0
Vital signs: 5 and 60 mins and days 3, 5 and 8 post-BLZ-100 administration.
Adverse events: Continuous assessment for at least 7 days (study day 8) post-BLZ-100 administration.
Physical examinations: Days 3, 5 and 8 post-BLZ-100 administration.
Laboratory safety: Days 3 and 8 post-BLZ-100 administration.
Secondary outcome [1] 305998 0
Concentrations of BLZ-100 in the blood will be measured by collecting several blood sampled over time. The blood will be analysed by chemical means to determine the BLZ-100 concentration and these data will be used to calculate pharmacokinetic parameters.
Timepoint [1] 305998 0
1, 5, 15, 30, 60 and 90 minutes (min) and 2, 3, 4, 6, 8, 12 and 24 hours (h) post-administration.
Secondary outcome [2] 312745 0
Determination of a dose level for Phase 2 studies based on safety, measurement of fluorescence signal in lesions and pharmacokinetics.
Timepoint [2] 312745 0
End of study - approximately 14 months

Eligibility
Key inclusion criteria
1. Male or female patients age 18 years or older.
2. Known or suspected non-metastatic basal cell or squamous cell carcinomas equal to or greater than 10 mm longest diameter or non-metastatic melanoma equal to or greater than 6 mm longest diameter scheduled for excision, without advanced disease.
3. Written Informed Consent.
4. Agree to the use of effective contraceptive from Baseline and for 30 days after treatment if either male or female of child bearing potential.
5. Available for and able to comply with study requirements.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are lactating/breastfeeding
2. Women with a positive pregnancy test or who are planning to become pregnant during the duration of the study.
3. Life expectancy <6 months.
4. Karnofsky Performance Status of 70% or less.
5. The following laboratory abnormalities:
a) Neutrophil count <1.5 x 109/L
b) Platelets <75 x 109/L
c) Haemoglobin <10 g/dL (may be determined following transfusion)
d) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal (ULN)
e) Total bilirubin >2x upper limit of reference range (unless Gilbert’s syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
f) International Normalized Ratio (INR) >1.5
g) Creatinine >1.5x ULN
6. History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization.
7. Uncontrolled asthma or asthma requiring oral corticosteroids.
8. Clinically significant chronic inflammatory skin conditions, including psoriasis, atopic dermatitis and scleroderma, as determined by the investigator.
9. Unstable angina, myocardial infarction, known or suspected transient ischemic events or stroke within 24 weeks of Screening.
10. Uncontrolled hypertension.
11. QTc prolongation >450 msec.
12. Receipt of photosensitising drugs within 30 days of screening.
13. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
14. 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.
15. Known or suspected sensitivity to study product or excipients.
16. Prior participation in this clinical trial (has received study product).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation is nonrandomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Dose escalation will follow the 3 + 3 design
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis
There will be no formal hypothesis testing. All analyses will be descriptive.

Recruitment
Recruitment status
Completed
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)
QLD
Recruitment postcode(s) [1] 7641 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 288436 0
Commercial sector/Industry
Name [1] 288436 0
Blaze Bioscience Australia Pty Ltd
Address [1] 288436 0
224 Hawthorn Road
Caulfield North, VIC 3161
Country [1] 288436 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Blaze Bioscience Australia Pty Ltd
Address
224 Hawthorn Road
Caulfield North, VIC 3161
Country
Australia
Secondary sponsor category [1] 287138 0
None
Name [1] 287138 0
Address [1] 287138 0
Country [1] 287138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290311 0
Bellberry Limited
Ethics committee address [1] 290311 0
129 Glen Osmond Road
Eastwood, SA 5063
Ethics committee country [1] 290311 0
Australia
Date submitted for ethics approval [1] 290311 0
Approval date [1] 290311 0
25/10/2013
Ethics approval number [1] 290311 0
2013-09-497

Summary
Brief summary
This study is evaluating the safety of a fluorescent marker (BLZ-100) used to visualise cancer cells in adults with skin cancer. Who is it for? You may be eligible to join this study if you are a male or female aged 18 years or above who has been diagnosed with non-melanotic skin cancer (e.g. non metastatic basal cell or squamous cell carcinomas or amelanotic melanoma) and are scheduled for surgical excision. Many types of cancer are primarily treated with surgery and the extent of surgical removal of the tumour is directly related to patient survival. However, it is often difficult for surgeons to distinguish tumour tissue from normal tissue or to detect tumour cells that have spread from the original tumour site. In addition, in some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumour to prevent adverse effects on function. In this study all participants will be administered BLZ-100 intravenously (i.e. directly into the vein) approximately 48 hours before scheduled excision of cancer lesions. BLZ-100 is a targeted fluorescent molecule that belongs to a class of products known as Tumor Paint (Trademark) bioconjugates designed to illuminate cancer cells to facilitate surgical resection. We hope that BLZ-100 will improve surgical outcomes by allowing surgeons to visualise the edges of the tumour and small groups of cancer cells in real-time, as they operate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45002 0
Dr Lynda Spelman
Address 45002 0
Veracity Clinical Research Pty Ltd
Specialist Connect Building
68 Ipswich Rd
Woolloongabba, QLD 4102
Country 45002 0
Australia
Phone 45002 0
+61 7 3039 1300
Fax 45002 0
Email 45002 0
info@specialistconnect.com.au
Contact person for public queries
Name 45003 0
Dr Errol Malta
Address 45003 0
Blaze Bioscience Australia Pty Ltd
224 Hawthorn Road
Caulfield North, VIC 3161
Country 45003 0
Australia
Phone 45003 0
+61 3 9629 6111
Fax 45003 0
Email 45003 0
errol.malta@blazebioscience.com
Contact person for scientific queries
Name 45004 0
Dr Dennis Miller
Address 45004 0
Blaze Bioscience Inc
530 Fairview Avenue North
Suite 1400
Seattle, WA 98109
Country 45004 0
United States of America
Phone 45004 0
+1 206 535 8144
Fax 45004 0
Email 45004 0
info@blazebioscience.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary