A Phase 1 interventional study of BLZ-100 in Sarcoma, Soft Tissue, sponsored by Blaze Bioscience Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-26.
Sponsored by Blaze Bioscience Inc. · Phase 1 and Interventional
Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue, and failure to surgically remove a cancer-affected lymph node or residual cancer at the surgical margin reduces a patient's chance of survival. Moreover, damage to adjacent normal tissue during surgery can result in significant morbidity. The investigators hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time as they operate. This is a safety study to assess the safety of BLZ-100 in patients with soft tissue sarcoma undergoing surgery.
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
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Exclusion Criteria:
Any of the following laboratory abnormalities at Screening:
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).
Drug: BLZ-100
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.
Also known as: Tumor Paint
Number of participants with adverse events
Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
Time frame: Seven days after study drug administration
Change of concentration of BLZ-100 in the blood
BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
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
Fluorescence signal from areas of tumor and non-tumor
Fluorescent signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
Time frame: 1 day post-dose, 2-3 days post-dose, or 3-7 days post-dose
Ideal combination of dose and imaging interval
Fluorescent signal will be evaluated in sections of excised tumor and adjacent normal tissue to determine which imaging interval provides the optimal images.
Time frame: 1 day post-dose, 2-3 days post-dose, 3-7 days post-dose
This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Blaze Bioscience Inc.