xml: <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/NCT05986851</url>
    </required_header>
    <id_info>
      <org_study_id>CAN-401</org_study_id>
      <nct_id>NCT05986851</nct_id>
    </id_info>
    <brief_title>Phase 2 Study of Azeliragon in MGMT Unmethylated Glioblastoma</brief_title>
    <official_title>A Phase II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon in Patients With MGMT Unmethylated Glioblastoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cantex Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medpace, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Cantex Pharmaceuticals</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a phase 2 study to evaluate the safety and preliminary evidence of effectiveness of&#xD;
        azeliragon, in combination with radiation therapy, as an initial treatment of a form of&#xD;
        glioblastoma. Glioblastoma is a type of brain cancer that grows quickly and can invade and&#xD;
        destroy healthy tissue. There's no cure for glioblastoma, which is also known as glioblastoma&#xD;
        multiforme. Treatments, including surgery, radiation, and chemotherapy might slow cancer&#xD;
        growth and reduce symptoms. New treatments of glioblastoma are needed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study to be conducted is a phase 2 study in newly diagnosed &quot;unmethylated&quot; glioblastoma.&#xD;
  &#xD;
        As compared to &quot;methylated&quot; glioblastoma &quot;unmethylated&quot; glioblastoma carries a worse&#xD;
        prognosis, as it is resistant to temozolomide, the most commonly prescribed chemotherapeutic&#xD;
        treatment. Based upon pre-clinical evidence suggesting that azeliragon may enhance the&#xD;
        effectiveness of radiation, as well as have a delaying effect on disease progression, this&#xD;
        study will combine daily oral azeliragon with radiation treatment, followed by continued&#xD;
        administration of azeliragon after completion of radiation therapy.&#xD;
  &#xD;
        Azeliragon is administered once daily as an oral capsule. In previous studies in patients&#xD;
        with Alzheimer's disease and in normal volunteers, azeliragon was well tolerated for up to 18&#xD;
        months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>Phase 2</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>Progression-free survival</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>To evaluate the progression-free survival (PFS) of newly diagnosed unmethylated GBM treated with the combination of RT and azeliragon.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>To evaluate the overall survival (OS) of newly diagnosed unmethylated GBM after RT and azeliragon</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Response rate</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>To evaluate overall response rate and duration of response as per RANO criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Steroid requirement</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>To evaluate the impact of azeliragon on the requirement of dexamethasone after RT</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Glioblastoma</condition>
    <arm_group>
      <arm_group_label>Daily oral azeliragon</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Azeliragon to be administered once daily for several days before, during, and after radiation therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Azeliragon</intervention_name>
      <description>Oral capsule</description>
      <arm_group_label>Daily oral azeliragon</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Histopathologically proven diagnosis of IDH-wildtype glioblastoma (GBM, WHO grade&#xD;
               4) according to the 2021 WHO classification (including subtypes such as gliosarcoma).&#xD;
  &#xD;
               2. Diagnosis must be established by open biopsy or tumor resection. Patients who have&#xD;
               only had a stereotactic biopsy are not eligible.&#xD;
  &#xD;
               3. Supratentorial location. 4. MGMT promoter methylation is negative based on local&#xD;
               CLIA-certified commercial laboratory tests.&#xD;
  &#xD;
               5. Must have recovered from the effects of surgery, postoperative infection, and other&#xD;
               complications at the time the patient signs the informed consent and is determined to&#xD;
               be eligible to participate in the study, as deemed eligible to participate per PI and&#xD;
               sub-investigator.&#xD;
  &#xD;
               6. ≥ 18 years old. 7. Karnofsky performance status ≥ 60. 8. A diagnostic&#xD;
               contrast-enhanced MRI or CT scan (if MRI is not available) of the brain must be&#xD;
               performed preoperatively and postoperatively. The postoperative scan must be done&#xD;
               within 21 days of the signing of informed consent prior to the initiation of&#xD;
               radiotherapy. Preoperative and postoperative scans must be the same type. If CT scans&#xD;
               were performed perioperatively, a CT should be performed before the signing of the&#xD;
               informed consent.&#xD;
  &#xD;
               9. Study therapy must begin ≤ 7 weeks after the most recent brain tumor surgery.&#xD;
  &#xD;
               10. Adequate organ and bone marrow function as defined below:&#xD;
  &#xD;
                 -  Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3;&#xD;
  &#xD;
                 -  Untransfused platelet count ≥ 75,000 cells/mm3;&#xD;
  &#xD;
                 -  Hemoglobin &gt; 9.0 g/dL (Note: the use of transfusion or other intervention to&#xD;
                    achieve Hgb &gt;9.0 g/dL is acceptable);&#xD;
  &#xD;
                 -  Total bilirubin ≤ 1.5 ULN&#xD;
  &#xD;
                 -  AST (SGOT) and ALT (SGPT) ≤ 3x ULN 11. • Creatinine ≤ 1.5 ULN or creatinine&#xD;
                    clearance ≥ 60 mL/min using the CKD- EPI Creatinine Equation&#xD;
  &#xD;
                 -  If there is history of human immunodeficiency virus (HIV) infection, patients&#xD;
                    must be on effective antiretroviral therapy, and HIV viral load must be&#xD;
                    undetectable within 6 months of study enrollment.&#xD;
  &#xD;
                 -  If there is history of chronic hepatitis B virus (HBV) infection, patients must&#xD;
                    have either been treated or are on suppressive therapy (as indicated), and HBV&#xD;
                    viral load must be undetectable.&#xD;
  &#xD;
                 -  If there is history of hepatitis C virus (HCV) infection, patients must have been&#xD;
                    treated, and HCV viral load must be undetectable.&#xD;
  &#xD;
                    12. Females of childbearing potential (defined as a female who is non-menopausal&#xD;
                    or surgically sterilized) must be willing to use an acceptable method of birth&#xD;
                    control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with&#xD;
                    spermicide, condom with spermicide, or abstinence) for the duration of the study.&#xD;
                    Should a woman become pregnant or suspect she is pregnant while participating in&#xD;
                    this study, she must inform her treating physician immediately 13. Patient has&#xD;
                    been informed about the nature of the study, and has agreed to participate in the&#xD;
                    study, and signed the Informed Consent Form (ICF) prior to participation in any&#xD;
                    study-related activities (legally authorized representative permitted).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease&#xD;
               free or not requiring active therapy for ≥ 3 years. (For example, carcinoma in situ of&#xD;
               the breast, oral cavity, and cervix are all permissible).&#xD;
  &#xD;
            2. Prior cranial RT or RT to the head and neck where potential field overlap may exist.&#xD;
  &#xD;
            3. Prior use of carmustine (Gliadel) wafers or any other intratumoral or intracavitary&#xD;
               treatment.&#xD;
  &#xD;
            4. Recurrent or multicentric disease. Multicentric disease is defined as multiple&#xD;
               discrete areas of tumor without connecting T2 signal abnormality.&#xD;
  &#xD;
            5. Infratentorial disease or metastatic disease beyond the brain.&#xD;
  &#xD;
            6. Known IDH mutation. IDH status could be determined by either immunohistochemistry or&#xD;
               sequencing as evaluated per routine clinical care.&#xD;
  &#xD;
            7. Patients with a serious active infection (such as a wound infection requiring&#xD;
               parenteral antibiotics) at the time of study entry or other serious underlying medical&#xD;
               conditions that would impair the ability of the patient to receive protocol treatment&#xD;
  &#xD;
            8. Patients with any condition (e.g., psychological, geographical, etc.) that does not&#xD;
               permit compliance with the protocol.&#xD;
  &#xD;
            9. Patients receiving CYP 2C8 inhibitors noted in Section 6.3&#xD;
  &#xD;
           10. Patient is unwilling or unable to comply with study procedures, including, but not&#xD;
               limited to self-administration of oral medication&#xD;
  &#xD;
           11. Patients with a gastrointestinal condition that could interfere with swallowing or&#xD;
               absorption&#xD;
  &#xD;
           12. Pregnant or breast feeding. Women of childbearing potential must a negative pregnancy&#xD;
               test within 14 days of study entry. Females of childbearing potential who are sexually&#xD;
               active or males with female partners of childbearing potential, where either the&#xD;
               female or the male is unwilling to use a highly effective method of contraception&#xD;
               during the trial and for 6 months after the last administration of azeliragon&#xD;
  &#xD;
           13. Patients with concurrent participation in another interventional clinical trial or use&#xD;
               of another investigational agent within 30 days prior to study entry. Patients who are&#xD;
               participating in non-interventional clinical trials (e.g., QOL, imaging,&#xD;
               observational, follow-up studies, etc.) are eligible, regardless of the timing of&#xD;
               participation&#xD;
  &#xD;
               -&#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_contact>
      <last_name>Stephen G Marcus, MD</last_name>
      <phone>9543153660</phone>
      <email>info@cantex.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Unmethylated</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glioblastoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986851
  org study id: CAN-401
  nct id: NCT05986851
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a phase 2 study to evaluate the safety and preliminary evidence of effectiveness of
        azeliragon, in combination with radiation therapy, as an initial treatment of a form of
        glioblastoma. Glioblastoma is a type of brain cancer that grows quickly and can invade and
        destroy healthy tissue. There's no cure for glioblastoma, which is also known as glioblastoma
        multiforme. Treatments, including surgery, radiation, and chemotherapy might slow cancer
        growth and reduce symptoms. New treatments of glioblastoma are needed.
  The study to be conducted is a phase 2 study in newly diagnosed "unmethylated" glioblastoma.
  
        As compared to "methylated" glioblastoma "unmethylated" glioblastoma carries a worse
        prognosis, as it is resistant to temozolomide, the most commonly prescribed chemotherapeutic
        treatment. Based upon pre-clinical evidence suggesting that azeliragon may enhance the
        effectiveness of radiation, as well as have a delaying effect on disease progression, this
        study will combine daily oral azeliragon with radiation treatment, followed by continued
        administration of azeliragon after completion of radiation therapy.
  
        Azeliragon is administered once daily as an oral capsule. In previous studies in patients
        with Alzheimer's disease and in normal volunteers, azeliragon was well tolerated for up to 18
        months.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression-free survival
  time frame: Up to 2 years
  description: To evaluate the progression-free survival (PFS) of newly diagnosed unmethylated GBM treated with the combination of RT and azeliragon.
  measure: Overall survival
  time frame: Up to 2 years
  description: To evaluate the overall survival (OS) of newly diagnosed unmethylated GBM after RT and azeliragon
  measure: Response rate
  time frame: Up to 2 years
  description: To evaluate overall response rate and duration of response as per RANO criteria
  measure: Steroid requirement
  time frame: Up to 2 years
  description: To evaluate the impact of azeliragon on the requirement of dexamethasone after RT
  arm group label: Daily oral azeliragon
  arm group type: Experimental
  description: Azeliragon to be administered once daily for several days before, during, and after radiation therapy.
  intervention type: Drug
  intervention name: Azeliragon
  description: Oral capsule
  arm group label: Daily oral azeliragon
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stephen G Marcus, MD
  phone: 9543153660
  email: info@cantex.com
  responsible party type: Sponsor
  mesh term: Glioblastoma
  sharing ipd: No