Safety Study of BLZ-100 in Adult Subjects With Glioma Undergoing Surgery
|ClinicalTrials.gov Identifier: NCT02234297|
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Drug: BLZ-100||Phase 1|
Subjects who provide voluntary written informed consent will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.
Subjects will be required to arrive at the hospital (or phase 1 unit if applicable) for dosing at least 2 hours before the planned surgical excision. Following dosing, subjects will be monitored for safety and surgical excision will occur at least 2 hours after study product administration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 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 Glioma Undergoing Surgery|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||March 2016|
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.
- Change in concentration of BLZ-100 in the blood [ Time Frame: Prior to dosing and at 1 minute, 5 minutes, 15 mins, 30 mins, 60 mins and 120 mins after end of injection ]BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
- Fluoresence signal in excised brain tumor and normal brain cancer [ Time Frame: at least 2 hours post-dose ]Fluorescence signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234297
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Brisbane, Queensland, Australia, Auchenflower|
|Principal Investigator:||Chirag Patil||Cedars-Sinai Medical Center|