A safety study of a fluorescent marker to visualise cancer cells

Phase 1

Completed

• Conditions: Skin cancer; Cancer - Non melanoma skin cancer; Cancer - Malignant melanoma

• Registration Number: ACTRN12614000115639
• Lead Sponsor: Blaze Bioscience Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

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.

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

• Study Type: Interventional
• Study Design: Not specified