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/NCT05979298</url>
    </required_header>
    <id_info>
      <org_study_id>PROC0319</org_study_id>
      <nct_id>NCT05979298</nct_id>
    </id_info>
    <brief_title>Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer</brief_title>
    <official_title>Open Label Randomized Clinical Study of Plasmid Encoding p62/SQSTM1 (ELenagen) in in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CureLab Oncology</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CureLab Oncology</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Phase II, two arm prospective study of efficacy and safety of ELENAGEN in combination with&#xD;
        gemcitabine in comparison with gemcitabine alone in patients with platinum-resistant ovarian&#xD;
        cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this clinical study is to evaluate safety and efficacy of ELENAGEN, a novel&#xD;
        anticancer therapeutics (plasmid DNA encoding p62/SQSTM1) protein, as an adjuvant to&#xD;
        chemotherapy with Gemcitabin (GEM) in patients with advanced platinum-resistant ovarian&#xD;
        cancer.&#xD;
  &#xD;
        This is a prospective randomized multi-center study with two arms. Gemcitabine 1000 mg/m2&#xD;
        days 1,8 every 3 weeks) is administered in both arms: In the Chemo arm (n = 20) Gemcitabine&#xD;
        is the only treatment, and in the ELENAGEN arm (n = 20) GEM was supplemented with ELENAGEN&#xD;
        (2.5 mg i.m. weekly). The primary endpoint is progression-free survival (PFS), and the&#xD;
        secondary endpoint is safety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 15, 2019</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This was a prospective randomized multi-center study with two arms. Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks) was administered in both arms: In the Chemo arm (n = 20) GEM was the only treatment, and in the ELENAGEN arm (n = 20) GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>2 years since the start of treatment</time_frame>
      <description>Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety of Elenagen in combination with Gemcitabine</measure>
      <time_frame>1 year after the start of treatment</time_frame>
      <description>Frequency of drug-related adverse events (AEs) and serious AEs (SAEs) according to NCI CTCAE version 5.0.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Ovarian Cancer</condition>
    <condition>Platinum-resistant Ovarian Cancer</condition>
    <arm_group>
      <arm_group_label>Gemcitabin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gemcitabine+Elenagen</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>Chemotherapeutics</description>
      <arm_group_label>Gemcitabin</arm_group_label>
      <arm_group_label>Gemcitabine+Elenagen</arm_group_label>
      <other_name>Gemzar</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>ELENAGEN</intervention_name>
      <description>DNA plasmid</description>
      <arm_group_label>Gemcitabine+Elenagen</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patient is 18-70 years old.&#xD;
  &#xD;
            -  Written informed consent of the patient to participate in clinical trials.&#xD;
  &#xD;
            -  Presence of histologically confirmed ovarian cancer.&#xD;
  &#xD;
            -  The return of the disease occurred less than 6 months after the last administration of&#xD;
               platinum.&#xD;
  &#xD;
            -  Presence of measurable tumor lesions according to RECIST 1.1 criteria.&#xD;
  &#xD;
            -  Functional status according to ECOG scale is 0-2.&#xD;
  &#xD;
            -  Life expectancy of at least 6 months.&#xD;
  &#xD;
            -  Adequate function of the organs as determined by the following criteria:&#xD;
  &#xD;
                 1. Absolute number of neutrophils (ANN) ≥1500/mm3 (≥1.5 × 109/l);&#xD;
  &#xD;
                 2. Platelet count ≥100,000/mm3 (IU: ≥100 × 109/l).&#xD;
  &#xD;
                 3. Hemoglobin level ≥ 9.0 g/dL determined by analysis performed at least 2 weeks&#xD;
                    after the last hemotransfusion;&#xD;
  &#xD;
                 4. The level of AST and ALT in blood serum not exceeding more than 3 times the upper&#xD;
                    limit of the norm.&#xD;
  &#xD;
                 5. The level of serum bilirubin not exceeding more than 1.5 times the upper limit of&#xD;
                    normal.&#xD;
  &#xD;
                 6. Serum Creatinine ≤ 1.5 mg/dL.&#xD;
  &#xD;
            -  The ability of the patient to follow the directions of the research physician and&#xD;
               follow the study regimen.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Criteria by which patients are not included in the study&#xD;
  &#xD;
            -  Platinum-sensitive relapse of ovarian cancer (disease recurrence occurred more than 6&#xD;
               months after the last administration of platinum drugs).&#xD;
  &#xD;
            -  Presence of serious diseases or health conditions:&#xD;
  &#xD;
                 1. Other malignancies, with the exception of malignancies treated more than 5 years&#xD;
                    ago without signs of return of the disease.&#xD;
  &#xD;
                 2. Brain metastases or leptomeningeal metastases.&#xD;
  &#xD;
                 3. Active infection (e.g. fever ≥38 °C), including active or unresolved&#xD;
                    pneumonia/pneumonitis.&#xD;
  &#xD;
                 4. Uncontrolled diabetes mellitus.&#xD;
  &#xD;
                 5. Myocardial Infarction in the last 12 months, severe/unstable angina, clinically&#xD;
                    manifested heart failure class III-IV according to the classification of the New&#xD;
                    York Cardiology Association (NYCA).&#xD;
  &#xD;
                 6. Gastrointestinal bleeding within the last 2 weeks.&#xD;
  &#xD;
                 7. Human immunodeficiency virus (HIV), chronic or acute hepatitis B or hepatitis C.&#xD;
  &#xD;
                 8. Patients with autoimmune disorders or organ transplantation who require&#xD;
                    immunosuppressive therapy.&#xD;
  &#xD;
          I. Mental illness that may increase the risk associated with participation in the study or&#xD;
          taking the study drug or that may affect the interpretation of the results of the study.&#xD;
  &#xD;
          K. Polyallergy, bronchial asthma (including aspirin) in history.&#xD;
  &#xD;
            -  Major surgery during the previous 4 weeks (complete wound healing).&#xD;
  &#xD;
            -  Previous chemotherapeutic treatment of the patient according to the scheme GEMCITABINE&#xD;
  &#xD;
            -  Radiotherapy with extended field radiation within the previous 4 weeks or radiotherapy&#xD;
               with a limited field radiation within the previous 2 weeks.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Ovarian cancer</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Minsk City Clinical Oncology Center</name>
        <address>
          <city>Minsk</city>
          <country>Belarus</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belarus</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gemcitabine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Not to be shared</ipd_description>
    </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/NCT05979298
  org study id: PROC0319
  nct id: NCT05979298
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Phase II, two arm prospective study of efficacy and safety of ELENAGEN in combination with
        gemcitabine in comparison with gemcitabine alone in patients with platinum-resistant ovarian
        cancer.
  The purpose of this clinical study is to evaluate safety and efficacy of ELENAGEN, a novel
        anticancer therapeutics (plasmid DNA encoding p62/SQSTM1) protein, as an adjuvant to
        chemotherapy with Gemcitabin (GEM) in patients with advanced platinum-resistant ovarian
        cancer.
  
        This is a prospective randomized multi-center study with two arms. Gemcitabine 1000 mg/m2
        days 1,8 every 3 weeks) is administered in both arms: In the Chemo arm (n = 20) Gemcitabine
        is the only treatment, and in the ELENAGEN arm (n = 20) GEM was supplemented with ELENAGEN
        (2.5 mg i.m. weekly). The primary endpoint is progression-free survival (PFS), and the
        secondary endpoint is safety.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This was a prospective randomized multi-center study with two arms. Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks) was administered in both arms: In the Chemo arm (n = 20) GEM was the only treatment, and in the ELENAGEN arm (n = 20) GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly).
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression-free survival (PFS)
  time frame: 2 years since the start of treatment
  description: Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death
  measure: Safety of Elenagen in combination with Gemcitabine
  time frame: 1 year after the start of treatment
  description: Frequency of drug-related adverse events (AEs) and serious AEs (SAEs) according to NCI CTCAE version 5.0.
  arm group label: Gemcitabin
  arm group type: Active Comparator
  description: Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks
  arm group label: Gemcitabine+Elenagen
  arm group type: Experimental
  description: GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)
  intervention type: Drug
  intervention name: Gemcitabine
  description: Chemotherapeutics
  arm group label: Gemcitabin
  arm group label: Gemcitabine+Elenagen
  other name: Gemzar
  intervention type: Biological
  intervention name: ELENAGEN
  description: DNA plasmid
  arm group label: Gemcitabine+Elenagen
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Ovarian cancer
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Belarus
  responsible party type: Sponsor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  mesh term: Gemcitabine
  sharing ipd: No
  ipd description: Not to be shared