Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery
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|ClinicalTrials.gov Identifier: NCT02464332|
Recruitment Status : Withdrawn (Study did not enroll any subjects)
First Posted : June 8, 2015
Last Update Posted : May 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma, Soft Tissue||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.
This is a two part study:
Part 1 - Dose Finding: Subjects will be required to arrive at the phase 1 unit for dosing 2-3 days prior to the planned surgical excision. Two dose levels of BLZ-100 (3 mg and 12 mg) will be evaluated in a total of 6 subjects with a 2-3 day post-dose imaging interval (also defined as the Intermediate Imaging interval).
Part 2 - Imaging Interval Assessment: The BLZ-100 dose to be evaluated in Part 2 will be determined by the Protocol Steering Committee following completion of Part 1. In Part 2, up to 15 additional subjects will be randomized into one of three imaging interval groups (up to 6 subjects per group): Early Imaging (within 1 day post BLZ-100 dose), Intermediate Imaging (2-3 days post BLZ-100 dose), and Late Imaging (4-7 days post BLZ-100 dose). Subjects will be required to arrive at the phase 1 unit for dosing between 1 and 7 days prior to planned surgical excision, depending on which imaging interval they are randomized to.
Following dosing, all subjects will be monitored for safety.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of BLZ-100 Administered by Intravenous Injection in Subjects With Soft Tissue Sarcoma Undergoing Surgery|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
All participants in the study will receive the investigational drug product BLZ-100.
In part 1 of the study, two dose levels of BLZ-100 will be evaluated (3 mg and 12 mg) in 6 subjects, with a 2-3 post-dose imaging window.
In part 2 of the study up to 15 additional subjects will be randomized to one of three imaging interval groups (up to 6 subjects/interval): Early Imaging (within 1 day post-BLZ-100 dose), Intermediate Imaging (2 - 3 days post- BLZ-100 dose), and Late Imaging (4 - 7 days post- BLZ-100 dose).
All subjects enrolled in the study will receive doses of BLZ-100, an investigational drug for imaging tumors.
Three different imaging windows will be investigated during the study:
Early Imaging (imaging occurs within 1 day post-BLZ-100 dose); Intermediate Imaging (imaging occurs within 2-3 days post-BLZ-100 dose); Late Imaging (imaging occurs 4-7 post-BLZ-100 dose)
All subjects in Part 1 of the study will be imaged in the Intermediate Imaging group. Subjects in Part 2 of the study will be randomized into one of the three imaging groups.
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 of concentration of BLZ-100 in the blood [ Time Frame: Prior to dosing and at 1 minute, 5 minutes, 15 minutes, 30 minutes, 60 minutes and 120 minutes after end of injection, and pre-surgery and 24 hours post-surgery ]BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
- Fluorescence signal from areas of tumor and non-tumor [ Time Frame: 1 day post-dose, 2-3 days post-dose, or 3-7 days post-dose ]Fluorescent signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
- Ideal combination of dose and imaging interval [ Time Frame: 1 day post-dose, 2-3 days post-dose, 3-7 days post-dose ]Fluorescent signal will be evaluated in sections of excised tumor and adjacent normal tissue to determine which imaging interval provides the optimal images.
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): NCT02464332
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||Charles Forscher, MD||Cedars-Sinai Medical Center|