- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02496065
Exploratory Study of Safety and ex Vivo Fluorescence of BLZ-100 in Adult Subjects With Solid Tumors Undergoing Surgery
A Phase 1 Exploratory Study of the Safety and ex Vivo Fluorescence of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Solid Tumors Undergoing Surgery
Study Overview
Detailed Description
Subjects diagnosed to have breast cancer for which surgical resection is clinically indicated will be enrolled in this study.
Upon obtaining signed informed consent, subjects will enter a Screening Period for up to 14 days to determine eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate in the study.
All subjects entered into the study will be required to arrive at the hospital (or Phase 1 unit if applicable) for BLZ-100 administration at least 2 hours before their scheduled surgical procedure. Following administration of BLZ-100, subjects will be continuously monitored for safety and any allergic reaction occurrence for 30 minutes; thereafter, subjects will be evaluated for 7 days after drug administration. All subjects will be followed for at least 30 days following drug administration to monitor for SAEs.
Tumor samples will be imaged in situ and ex vivo with the SIRIS imaging system or equivalent device, processed, and sent to a central laboratory to be evaluated for ex vivo fluorescence using the Odyssey® CLx imaging system.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Washington
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Bellevue, Washington, United States, 98004
- Overlake Medical Center
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female subject aged 18 years or older.
- Diagnosed solid tumor scheduled for surgical excision. Subjects with recurrent disease will be eligible only if the duration between last tumor surgery and scheduled new surgery is ≥3 months.
- Able to provide written informed consent.
- If of child-bearing potential, agree to continued use of two reliable methods of contraceptive from study entry (time of informed consent) through 30 days after BLZ-100 administration. Male subjects with vasectomy do not need to use a second form of contraceptive.
- Available for all study visits and able to comply with all study requirements.
Exclusion Criteria:
- Suspected central nervous system (CNS) tumor(s) or sarcoma.
- Female who is lactating/breastfeeding.
- Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study.
- Karnofsky Performance Status of <60%.
Any of the following laboratory abnormalities at Screening:
- Neutrophil count <1.5 x 109/L
- Platelets <75 x 109/L
- Hemoglobin <10 g/dL (may be determined following transfusion)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN)
- Total bilirubin >1.5 x ULN (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
- International Normalized Ratio (INR) >1.5 x ULN
- Creatinine >1.5 x ULN
- QTc prolongation >480 msec.
- History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine, and/or hospitalization.
- Uncontrolled asthma or asthma requiring oral corticosteroids.
- Known or suspected sensitivity to diagnostic imaging contrast agents.
- Known or suspected sensitivity to indocyanine green (ICG).
- Unstable angina, myocardial infarction, known or suspected transient ischemic events, or stroke within 24 weeks of start of Screening.
- Uncontrolled hypertension.
- Initiation of new photosensitizing drugs within 30 days of Screening.
- Use of any ongoing medications which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin®, and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix.
- Receipt of an investigational drug or device within 30 days of enrollment.
- Prior treatment with BLZ-100.
- Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would adversely impact the subject or the interpretation of the study data.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BLZ-100
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
These assessments will be used to determine whether a subject experienced an AE.
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Seven days after study drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fluorescent signal from excised tumor surgical specimens
Time Frame: Post-tumor excision (approximately 2 hours post BLZ-100 dosing)
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Ex vivo fluorescence of excised tumor specimens will be evaluated with the SIRIS or equivalent imaging device and Odyssey imaging system.
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Post-tumor excision (approximately 2 hours post BLZ-100 dosing)
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Change of concentration of BLZ-100 in the blood
Time Frame: 5, 15, and 30 minutes post BLZ-100 administration
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BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
|
5, 15, and 30 minutes post BLZ-100 administration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristi M Harrington, MD, Overlake Medical Center, Overlake Medical Clinics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BB-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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