<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/NCT01672463</url>
  </required_header>
  <id_info>
    <org_study_id>HCI57337</org_study_id>
    <nct_id>NCT01672463</nct_id>
  </id_info>
  <brief_title>Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients</brief_title>
  <acronym>OKN-007</acronym>
  <official_title>Phase 1b Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oblato, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oblato, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot&#xD;
      cohort of human recurrent malignant glioma patients. All patients will have been previously&#xD;
      treated with the standard-of-care treatment which includes surgical resection, radiation and&#xD;
      chemotherapy, and in some cases treatment for recurrent disease with investigational agents&#xD;
      or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established&#xD;
      by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic&#xD;
      acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on&#xD;
      this protocol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Actual">January 31, 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse events per patient</measure>
    <time_frame>24 months</time_frame>
    <description>The primary objective is to determine MTD, tolerance, and safety of OKN-007 in patients with recurrent GBM and anaplastic glioma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK level in participants</measure>
    <time_frame>24 months</time_frame>
    <description>To determine drug levels of OKN-007 in blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 month progression-free survival</measure>
    <time_frame>24 months</time_frame>
    <description>To determine radiographic response rate and 6 month Progression-Free Survival (PFS) of patients treated with OKN-007. PFS is defined as the time from first drug treatment until objective tumor progression or death.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">31</enrollment>
  <condition>Recurrent Malignant Glioma</condition>
  <arm_group>
    <arm_group_label>All patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants enrolled in this study</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OKN-007</intervention_name>
    <description>Dose escalation/PK cohort: 20 mg/kg, 40 mg/kg or 60 mg/kg OKN-007 via IV infusion, given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.&#xD;
Expansion cohort: MTD via IV infusion given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.</description>
    <arm_group_label>All patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed histopathology of WHO grade III glioma or WHO grade IV GBM at primary&#xD;
             diagnosis&#xD;
&#xD;
          2. Unequivocal radiographic evidence of tumor progression by MRI within 14 days prior to&#xD;
             registration&#xD;
&#xD;
          3. Prior radiotherapy&#xD;
&#xD;
          4. Prior Temozolomide treatment&#xD;
&#xD;
          5. Last cytotoxic chemotherapy 28 or more days or biologic therapy treatment 14 or more&#xD;
             days before study start (greater than or equal to 42 days if nitrosourea was&#xD;
             administered)&#xD;
&#xD;
          6. Karnofsky performance status greater than or equal to 60%&#xD;
&#xD;
          7. Full recovery (&lt; grade 1) from the toxic effects of any earlier intervention and a&#xD;
             minimum of 28 days from the administration of any investigational agent&#xD;
&#xD;
          8. Adequate renal, liver and bone marrow function:&#xD;
&#xD;
               -  Leukocytes &gt;3,000/mcL&#xD;
&#xD;
               -  Absolute neutrophil count &gt;1,500/mcL&#xD;
&#xD;
               -  Platelets &gt;100,000/mcL&#xD;
&#xD;
               -  Total bilirubin within normal limits&#xD;
&#xD;
               -  AST / ALT (SGPT) &lt;2.5 x ULN&#xD;
&#xD;
               -  Creatinine within normal limits&#xD;
&#xD;
          9. Patients must be &gt;_18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Second primary malignancy (except adequately treated basal cell carcinoma of the&#xD;
             skin). Patients who had another malignancy in the past, but have been free of active&#xD;
             disease for more than 2 years, are eligible&#xD;
&#xD;
          2. Have received treatment within the last 28 days with a drug that has not received&#xD;
             regulatory approval for any indication at the time of study entry&#xD;
&#xD;
          3. Serious concomitant systemic disorders (for example, active infection or abnormal&#xD;
             electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the&#xD;
             investigator, would compromise the safety of the patient and his/her ability to&#xD;
             complete the study&#xD;
&#xD;
          4. Patients with moderate or severe renal impairment (calculated creatinine clearance of&#xD;
             &lt; 60 mL/min)&#xD;
&#xD;
          5. Patients with sodium, potassium, or creatinine serum electrolytes &gt; grade 2.&#xD;
&#xD;
          6. Patients with PT/PTT above the upper limit of normal&#xD;
&#xD;
          7. Screening ECG abnormality documented by the investigator as medically significant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Battiste, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>• Oklahoma University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oklahoma University</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
    <mesh_term>Recurrence</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/NCT01672463
org study id: HCI57337
nct id: NCT01672463
lead sponsor: 
has dmc: Yes
This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot
      cohort of human recurrent malignant glioma patients. All patients will have been previously
      treated with the standard-of-care treatment which includes surgical resection, radiation and
      chemotherapy, and in some cases treatment for recurrent disease with investigational agents
      or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established
      by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic
      acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on
      this protocol.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Adverse events per patient
time frame: 24 months
description: The primary objective is to determine MTD, tolerance, and safety of OKN-007 in patients with recurrent GBM and anaplastic glioma.
measure: PK level in participants
time frame: 24 months
description: To determine drug levels of OKN-007 in blood.
measure: 6 month progression-free survival
time frame: 24 months
description: To determine radiographic response rate and 6 month Progression-Free Survival (PFS) of patients treated with OKN-007. PFS is defined as the time from first drug treatment until objective tumor progression or death.
arm group label: All patients
arm group type: Experimental
description: All participants enrolled in this study
intervention type: Drug
intervention name: OKN-007
description: Dose escalation/PK cohort: 20 mg/kg, 40 mg/kg or 60 mg/kg OKN-007 via IV infusion, given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.
Expansion cohort: MTD via IV infusion given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.
arm group label: All patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Battiste, MD, PhD
role: Principal Investigator
affiliation: • Oklahoma University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glioma
mesh term: Recurrence