Exploratory Study of Safety and ex Vivo Fluorescence of BLZ-100 in Adult Subjects With Solid Tumors Undergoing Surgery
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|ClinicalTrials.gov Identifier: NCT02496065|
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tumors, Breast||Drug: BLZ-100||Phase 1|
Subjects diagnosed to have breast cancer for which surgical resection is clinically indicated will be enrolled in this study.
Upon obtaining signed informed consent, subjects will enter a Screening Period for up to 14 days to determine eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate in the study.
All subjects entered into the study will be required to arrive at the hospital (or Phase 1 unit if applicable) for BLZ-100 administration at least 2 hours before their scheduled surgical procedure. Following administration of BLZ-100, subjects will be continuously monitored for safety and any allergic reaction occurrence for 30 minutes; thereafter, subjects will be evaluated for 7 days after drug administration. All subjects will be followed for at least 30 days following drug administration to monitor for SAEs.
Tumor samples will be imaged in situ and ex vivo with the SIRIS imaging system or equivalent device, processed, and sent to a central laboratory to be evaluated for ex vivo fluorescence using the Odyssey® CLx imaging system.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Exploratory Study of the Safety and ex Vivo Fluorescence of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Solid Tumors Undergoing Surgery|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||January 2017|
Other Name: Tumor Paint
- Number of participants with adverse events [ Time Frame: Seven days after study drug administration ]Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters. These assessments will be used to determine whether a subject experienced an AE.
- Fluorescent signal from excised tumor surgical specimens [ Time Frame: Post-tumor excision (approximately 2 hours post BLZ-100 dosing) ]Ex vivo fluorescence of excised tumor specimens will be evaluated with the SIRIS or equivalent imaging device and Odyssey imaging system.
- Change of concentration of BLZ-100 in the blood [ Time Frame: 5, 15, and 30 minutes post BLZ-100 administration ]BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
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): NCT02496065
|United States, Washington|
|Overlake Medical Center|
|Bellevue, Washington, United States, 98004|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Kristi M Harrington, MD||Overlake Medical Center, Overlake Medical Clinics|