Safety Study of a Fluorescent Marker to Visualize Cancer Cells

Skin Neoplasms Clinical Trial

Official title:

A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097875
• Other study ID #: BB-001
• Secondary ID: ACTRN12614000115
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2014
• Last updated: April 20, 2015
• Start date: December 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Blaze Bioscience Australia Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Neoplasms

Intervention

Drug:
• BLZ-100

Locations

Country	Name	City	State
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Blaze Bioscience Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in fluorescence signal in urine	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.	Prior to dosing and at 0-4, 4-8, 8-12, 12-24 and 24-48 hours post-dose	No
Other	Change in fluorescent signal in skin tumor and normal skin	Fluorescence signal in skin tumor and normal skin will be measured in situ using the Fluobeam(TM) infrared imaging system.	Prior to dosing on day 1 and at 2, 4, 24 and 48 hours post-dose	No
Other	Expression of biomarkers of response in excised skin tumor	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.	48 hours post-dose	No
Primary	Number of participants with adverse events	Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.	Within at least 1 week from baseline	Yes
Secondary	Change in concentration of BLZ-100 in the blood	BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.	Prior to dosing and 1, 5, 15, 30, 60 and 90 minutes and 2, 3, 4, 6, 8, 12 and 24 hours post-dose	No
Secondary	Determination of a dose level for Phase 2 studies		At end of study - approximately 14 months	No