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Safety Study of a Fluorescent Marker to Visualize Cancer Cells

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ClinicalTrials.gov Identifier: NCT02097875
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Blaze Bioscience Australia Pty Ltd

Tracking Information
First Submitted Date  ICMJE March 25, 2014
First Posted Date  ICMJE March 27, 2014
Last Update Posted Date April 21, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
Number of participants with adverse events [ Time Frame: Within at least 1 week from baseline ]
Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02097875 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
  • 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 ]
    BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
  • Determination of a dose level for Phase 2 studies [ Time Frame: At end of study - approximately 14 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
  • Change in concentration of BLZ-100 in the blood [ Time Frame: Prior to dosing and 1, 5, 15, 30 and 60 minutes and 2, 4, 8, 12, 24, 48, 96 and 168 hours post-dose ]
    BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
  • Fluorescence signal in excised skin tumor and normal skin [ Time Frame: 48 hours post-dose ]
    Fluorescence signal in sections of excised tumor and adjacent normal skin tissue will be measured using an infrared imaging system.
Current Other Pre-specified Outcome Measures
 (submitted: March 25, 2014)
  • 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 ]
    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.
  • 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 ]
    Fluorescence signal in skin tumor and normal skin will be measured in situ using the Fluobeam(TM) infrared imaging system.
  • Expression of biomarkers of response in excised skin tumor [ Time Frame: 48 hours post-dose ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety Study of a Fluorescent Marker to Visualize Cancer Cells
Official Title  ICMJE A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Skin Neoplasms
Intervention  ICMJE Drug: BLZ-100
Study Arms  ICMJE 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.
Intervention: Drug: BLZ-100
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
21
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2014)
30
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02097875
Other Study ID Numbers  ICMJE BB-001
ACTRN12614000115639 ( Registry Identifier: ANZCTR )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Blaze Bioscience Australia Pty Ltd
Study Sponsor  ICMJE Blaze Bioscience Australia Pty Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lynda Spelman, MBBS FACD Veracity Clinical Research Pty Ltd
PRS Account Blaze Bioscience Australia Pty Ltd
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP