<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02234297</url>
  </required_header>
  <id_info>
    <org_study_id>BB-002</org_study_id>
    <nct_id>NCT02234297</nct_id>
  </id_info>
  <brief_title>Safety Study of BLZ-100 in Adult Subjects With Glioma Undergoing Surgery</brief_title>
  <official_title>A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Glioma Undergoing Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Blaze Bioscience Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Blaze Bioscience Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many types of cancer are primarily treated with surgery and patient survival is directly&#xD;
      related to the extent to which the tumor is able to be removed. It is often difficult for&#xD;
      surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have&#xD;
      spread from the original tumor site, resulting in incomplete removal of the tumor and reduced&#xD;
      patient survival. In some sites, such as the brain, it is critical to avoid damage to normal&#xD;
      tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize&#xD;
      that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of&#xD;
      the tumor and small groups of cancer cells that have spread to other sites in real-time as&#xD;
      operate. This is a safety study to assess the safety of BLZ-100 in patients with gliomas&#xD;
      undergoing surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects who provide voluntary written informed consent will be screened for eligibility.&#xD;
      Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to&#xD;
      participate.&#xD;
&#xD;
      Subjects will be required to arrive at the hospital (or phase 1 unit if applicable) for&#xD;
      dosing at least 2 hours before the planned surgical excision. Following dosing, subjects will&#xD;
      be monitored for safety and surgical excision will occur at least 2 hours after study product&#xD;
      administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>Seven days after study drug administration</time_frame>
    <description>Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in concentration of BLZ-100 in the blood</measure>
    <time_frame>Prior to dosing and at 1 minute, 5 minutes, 15 mins, 30 mins, 60 mins and 120 mins after end of injection</time_frame>
    <description>BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fluoresence signal in excised brain tumor and normal brain cancer</measure>
    <time_frame>at least 2 hours post-dose</time_frame>
    <description>Fluorescence signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Glioma</condition>
  <arm_group>
    <arm_group_label>BLZ-100</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLZ-100</intervention_name>
    <arm_group_label>BLZ-100</arm_group_label>
    <other_name>Tumor Paint</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects aged 18- 75 years.&#xD;
&#xD;
          2. Subjects must have glioma for which surgical resection is clinically indicated. Grade&#xD;
             I, II, III and IV glioma patients will be included (for example glioblastoma,&#xD;
             astrocytoma, and oligodendroglioma). Histological confirmation not required prior to&#xD;
             surgery. Subjects with recurrent disease will be eligible only if the duration between&#xD;
             last brain surgery and scheduled new surgery is ≥3 months. The grade of a recurrent&#xD;
             tumor will be presumed that of the primary tumor for purposes of group allocation.&#xD;
&#xD;
          3. Able to provide written informed consent.&#xD;
&#xD;
          4. If of child-bearing potential, agree to the continued use of effective contraceptive&#xD;
             from study entry (Informed consent) through 30 days after BLZ-100 administration.&#xD;
&#xD;
          5. Available for all study visits and able to comply with all study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of metastatic disease.&#xD;
&#xD;
          2. Female who is lactating/breastfeeding&#xD;
&#xD;
          3. Female with a positive pregnancy test or who is planning to become pregnant during the&#xD;
             duration of the study.&#xD;
&#xD;
          4. Karnofsky Performance Status of &lt;60%.&#xD;
&#xD;
          5. Any of the following laboratory abnormalities at Screening:&#xD;
&#xD;
               1. Neutrophil count &lt;1.5 x 10^9/L&#xD;
&#xD;
               2. Platelets &lt;75 x 10^9/L&#xD;
&#xD;
               3. Hemoglobin &lt;10 g/dL (may be determined following transfusion)&#xD;
&#xD;
               4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) &gt; 3x upper&#xD;
                  limit of normal (ULN)&#xD;
&#xD;
               5. Total bilirubin &gt;1.5x upper limit of reference range (unless Gilbert's syndrome&#xD;
                  or extrahepatic source as denoted by increased indirect bilirubin fraction)&#xD;
&#xD;
               6. International Normalized Ratio (INR) &gt;1.5&#xD;
&#xD;
               7. Creatinine &gt;1.5x ULN&#xD;
&#xD;
          6. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or&#xD;
             hepatitis B virus (HBV).&#xD;
&#xD;
          7. QTc prolongation &gt;450 msec&#xD;
&#xD;
          8. History of hypersensitivity or allergic reactions requiring corticosteroids,&#xD;
             epinephrine and/or hospitalization.&#xD;
&#xD;
          9. Uncontrolled asthma or asthma requiring oral corticosteroids.&#xD;
&#xD;
         10. Known or suspected sensitivity to MRI contrast agents or excipients in the study drug&#xD;
             product.&#xD;
&#xD;
         11. Known or suspected sensitivity to Indocyanine green (ICG).&#xD;
&#xD;
         12. Unstable angina, myocardial infarction, known or suspected transient ischemic events&#xD;
             or stroke within 24 weeks of start of Screening.&#xD;
&#xD;
         13. Uncontrolled hypertension.&#xD;
&#xD;
         14. Receipt of photosensitizing drugs within 30 days of Screening.&#xD;
&#xD;
         15. Any ongoing medications which might generate fluorescence or according to label, might&#xD;
             generate a photochemical reaction. These include haematoporphyrin derivatives and&#xD;
             purified fractions; Photofrin®; and the precursors of protoporphyrin IX&#xD;
             (5-Aminolevulinic acid) used in Gliolan or Hexvix.&#xD;
&#xD;
         16. Received an investigational drug or device within 30 days of enrollment.&#xD;
&#xD;
         17. Prior treatment with BLZ-100.&#xD;
&#xD;
         18. Any concurrent condition, including psychological and social situations, which, in the&#xD;
             opinion of the investigator, would impact adversely on the subject or the&#xD;
             interpretation of the study data.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chirag Patil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NEWRO Foundation</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>Auchenflower</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>April 4, 2016</last_update_submitted>
  <last_update_submitted_qc>April 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glioma</keyword>
  <keyword>Tumor Paint</keyword>
  <keyword>BLZ100</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02234297
org study id: BB-002
nct id: NCT02234297
lead sponsor: 
has dmc: Yes
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 or to detect tumor cells that have
      spread from the original tumor site, resulting in incomplete removal of the tumor and reduced
      patient survival. In some sites, such as the brain, it is critical to avoid damage to normal
      tissue around the tumor to prevent adverse effects of surgery on function. We 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
      operate. This is a safety study to assess the safety of BLZ-100 in patients with gliomas
      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.

      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.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Number of participants with adverse events
time frame: Seven days after study drug administration
description: Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
measure: 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
description: BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.
measure: Fluoresence signal in excised brain tumor and normal brain cancer
time frame: at least 2 hours post-dose
description: Fluorescence signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.
arm group label: BLZ-100
arm group type: Experimental
intervention type: Drug
intervention name: BLZ-100
arm group label: BLZ-100
other name: Tumor Paint
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chirag Patil
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
facility: 
country: Australia
country: United States
responsible party type: Sponsor
mesh term: Glioma