- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02097875
Safety Study of a Fluorescent Marker to Visualize Cancer Cells
April 20, 2015 updated by: Blaze Bioscience Australia Pty Ltd
A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Queensland
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Woolloongabba, Queensland, Australia, 4102
- Veracity Clinical Research Pty Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events
Time Frame: Within at least 1 week from baseline
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Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
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Within at least 1 week from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in concentration of BLZ-100 in the blood
Time Frame: Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose
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BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
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Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose
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Determination of a dose level for Phase 2 studies
Time Frame: At end of study - approximately 14 months
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At end of study - approximately 14 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fluorescence signal in urine
Time Frame: Prior to dosing and at 0-4, 4-8, 8-12, 12-24 and 24-48 hours post-dose
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Fluorescence signal in urine samples will be measured using an infrared imaging system to determine the amount of BLZ-100 being excreted in the urine post-dosing.
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Prior to dosing and at 0-4, 4-8, 8-12, 12-24 and 24-48 hours post-dose
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Change in fluorescent signal in skin tumor and normal skin
Time Frame: Prior to dosing on day 1 and at 2, 4, 24 and 48 hours post-dose
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Fluorescence signal in skin tumor and normal skin will be measured in situ using the Fluobeam(TM) infrared imaging system.
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Prior to dosing on day 1 and at 2, 4, 24 and 48 hours post-dose
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Expression of biomarkers of response in excised skin tumor
Time Frame: 48 hours post-dose
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Immunohistochemistry will be used to measure the expression of other biomarkers of response, including Annexin A2, Ki67 and MMP2 (matrix metalloproteinase-2), in normal and tumor tissue.
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48 hours post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lynda Spelman, MBBS FACD, Veracity Clinical Research Pty Ltd
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (ACTUAL)
March 1, 2015
Study Completion (ACTUAL)
March 1, 2015
Study Registration Dates
First Submitted
March 25, 2014
First Submitted That Met QC Criteria
March 25, 2014
First Posted (ESTIMATE)
March 27, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
April 21, 2015
Last Update Submitted That Met QC Criteria
April 20, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BB-001
- ACTRN12614000115639 (REGISTRY: ANZCTR)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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