Safety Study of a Fluorescent Marker to Visualize Cancer Cells
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|