- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02234297
Safety Study of BLZ-100 in Adult Subjects With Glioma Undergoing Surgery
A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Glioma Undergoing Surgery
Study Overview
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.
Subjects will be required to arrive at the hospital (or phase 1 unit if applicable) for dosing at least 2 hours before the planned surgical excision. Following dosing, subjects will be monitored for safety and surgical excision will occur at least 2 hours after study product administration.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Queensland
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Brisbane, Queensland, Australia, Auchenflower
- Newro Foundation
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female subjects aged 18- 75 years.
- Subjects must have glioma for which surgical resection is clinically indicated. Grade I, II, III and IV glioma patients will be included (for example glioblastoma, astrocytoma, and oligodendroglioma). Histological confirmation not required prior to surgery. Subjects with recurrent disease will be eligible only if the duration between last brain surgery and scheduled new surgery is ≥3 months. The grade of a recurrent tumor will be presumed that of the primary tumor for purposes of group allocation.
- Able to provide written informed consent.
- If of child-bearing potential, agree to the continued use of effective contraceptive from study entry (Informed consent) through 30 days after BLZ-100 administration.
- Available for all study visits and able to comply with all study requirements
Exclusion Criteria:
- Evidence of metastatic disease.
- 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 10^9/L
- Platelets <75 x 10^9/L
- Hemoglobin <10 g/dL (may be determined following transfusion)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x upper limit of normal (ULN)
- Total bilirubin >1.5x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
- International Normalized Ratio (INR) >1.5
- Creatinine >1.5x ULN
- Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
- QTc prolongation >450 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 MRI contrast agents or excipients in the study drug product.
- 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.
- Receipt of photosensitizing drugs within 30 days of Screening.
- Any ongoing medications which might generate fluorescence or according to 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.
- Received 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 impact adversely on the subject or the interpretation of the study data.
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Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BLZ-100
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Other Names:
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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
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Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
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Seven days after study drug administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in concentration of BLZ-100 in the blood
Time Frame: Prior to dosing and at 1 minute, 5 minutes, 15 mins, 30 mins, 60 mins and 120 mins after end of injection
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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.
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Prior to dosing and at 1 minute, 5 minutes, 15 mins, 30 mins, 60 mins and 120 mins after end of injection
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Fluoresence signal in excised brain tumor and normal brain cancer
Time Frame: at least 2 hours post-dose
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Fluorescence signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
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at least 2 hours post-dose
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chirag Patil, Cedars-Sinai Medical Center
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 (Estimate)
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-002
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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