Safety Study of BLZ-100 in Adult Subjects With Glioma Undergoing Surgery
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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|
- Number of participants with adverse events [ Time Frame: Seven days after study drug administration ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Fluorescence signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
|Study Start Date:||October 2014|
|Study Completion Date:||March 2016|
|Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|