NCT02464332

Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery

A Phase 1 Study of BLZ-100 Administered by Intravenous Injection in Subjects With Soft Tissue Sarcoma Undergoing Surgery

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Blaze Bioscience Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-06-08
• Last updated: 2016-05-26

Locations

1 site across 1 country: United States