Safety Study of a Fluorescent Marker to Visualize Cancer Cells
|ClinicalTrials.gov Identifier: NCT02097875|
Recruitment Status : Completed
First Posted : March 27, 2014
Last Update Posted : April 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Skin Neoplasms||Drug: BLZ-100||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Skin Cancer|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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.
- 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.
- 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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097875
|Veracity Clinical Research Pty Ltd|
|Woolloongabba, Queensland, Australia, 4102|
|Principal Investigator:||Lynda Spelman, MBBS FACD||Veracity Clinical Research Pty Ltd|