Study of BLZ-100 in Pediatric Subjects With CNS Tumors
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02462629|
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Tumors||Drug: BLZ-100||Phase 1|
Subjects who provide voluntary written informed consent, or have it provided by their legally acceptable representative, 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 for dosing at least 1 hour before the planned surgical excision. Following dosing, subjects will be monitored for safety and surgical excision will occur at least 1 hour after study product administration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose-escalation and Expansion Study of BLZ-100 in Pediatric Subjects With Primary Central Nervous System Tumors|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||February 2018|
- 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 10 minutes, 30 minutes, and 60 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.
- Fluorescence signal in excised central nervous system tumors [ Time Frame: At least 1 hour post-dose ]Fluorescence signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
- Extent of resection (expansion cohort only) [ Time Frame: At completion of surgery for surgeon assessment and up to 1 week after surgery for MRI assessment ]For subjects enrolled in the expansion cohort, an extent of resection assessment will be made by the surgeon and confirmed by post-operative MRI according to standard of care procedures.
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): NCT02462629
|Contact: Advanced Therapeuticsfirstname.lastname@example.org|
|United States, Washington|
|Seattle, Washington, United States, 98105|
|Contact: Advanced Therapeutics email@example.com|
|Principal Investigator: Sarah Leary, MD, MS|
|Principal Investigator:||Sarah Leary, MD, MS||Seattle Children's|