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/NCT05998135</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00005363</org_study_id>
      <secondary_id>NCI-2023-03479</secondary_id>
      <secondary_id>STUDY00005363</secondary_id>
      <secondary_id>WINSHIP5782-22</secondary_id>
      <secondary_id>P30CA138292</secondary_id>
      <nct_id>NCT05998135</nct_id>
    </id_info>
    <brief_title>Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer</brief_title>
    <official_title>Phase II Clinical Trial Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Emory University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Emory University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This phase II trial test tests how well repurposing atovaquone works in treating patients&#xD;
        with platinum-resistant ovarian cancer. Atovaquone is used for the treatment or prevention of&#xD;
        certain infections. Atovaquone is in a class of medications called antiprotozoal agents. It&#xD;
        works by stopping the growth of certain types of protozoa that can cause pneumonia. Giving&#xD;
        atovaquone may be effective in treating platinum-resistant ovarian cancer and result in&#xD;
        improved outcomes compared to standard chemotherapy regimens.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To determine progression free survival of twenty-eight patients with platinum-resistant&#xD;
        ovarian cancer treated with atovaquone.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To determine clinical benefit rate (complete response, partial response or stable disease)&#xD;
        at six months.&#xD;
  &#xD;
        II. To determine overall survival. III. To quantitate the on-target STAT3 inhibitory effect&#xD;
        of atovaquone on STAT3-dependent gene transcription.&#xD;
  &#xD;
        IV. To quantitate changes of the tumor immune infiltrate by inhibition of STAT3 with&#xD;
        atovaquone.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients receive atovaquone orally (PO) on study. Patients also undergo computed tomography&#xD;
        (CT) and biopsy or paracentesis throughout the study.&#xD;
  &#xD;
        After completion of study treatment, patients are followed up for 30 days and then every 6&#xD;
        month thereafter.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 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 (PFS)</measure>
      <time_frame>From initiation of atovaquone to progression or death, assessed up to 1 year</time_frame>
      <description>Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical benefit rate</measure>
      <time_frame>At 6 months</time_frame>
      <description>Clinical benefit rate is defined as complete response, partial response, and/or stable disease at six months. Clinical response will be assessed every 6 weeks for the first 24 months and every 12 weeks thereafter using Response Evaluation Criteria in Solid Tumors 1.1 criteria. Will be estimated as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>From diagnosis to death from any cause, where patients who are alive will be censored at last follow-up date, assessed up to 1 year</time_frame>
      <description>OS will be estimated using the Kaplan-Meier method, and median survival will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>Up to 30 days</time_frame>
      <description>Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Frequencies and percentages will be used to summarize safety events.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Ovarian High Grade Serous Adenocarcinoma</condition>
    <condition>Platinum-Resistant Ovarian Carcinoma</condition>
    <arm_group>
      <arm_group_label>Treatment (atovaquone)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Atovaquone</intervention_name>
      <description>Given PO</description>
      <arm_group_label>Treatment (atovaquone)</arm_group_label>
      <other_name>566C80</other_name>
      <other_name>BW-566C</other_name>
      <other_name>BW-A566C</other_name>
      <other_name>Mepron</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biopsy</intervention_name>
      <description>Undergo biopsy</description>
      <arm_group_label>Treatment (atovaquone)</arm_group_label>
      <other_name>BIOPSY_TYPE</other_name>
      <other_name>Bx</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Computed Tomography</intervention_name>
      <description>Undergo CT</description>
      <arm_group_label>Treatment (atovaquone)</arm_group_label>
      <other_name>CAT</other_name>
      <other_name>CAT Scan</other_name>
      <other_name>Computed Axial Tomography</other_name>
      <other_name>Computerized Axial Tomography</other_name>
      <other_name>Computerized axial tomography (procedure)</other_name>
      <other_name>Computerized Tomography</other_name>
      <other_name>CT</other_name>
      <other_name>CT Scan</other_name>
      <other_name>tomography</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Paracentesis</intervention_name>
      <description>Undergo paracentesis</description>
      <arm_group_label>Treatment (atovaquone)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with platinum-resistant, high-grade serous ovarian cancer, defined as disease&#xD;
               progression within six months of completion of their last platinum-based chemotherapy&#xD;
  &#xD;
            -  Patients must maintain Eastern Cooperative Oncology Group (ECOG) performance status of&#xD;
               0 or 1&#xD;
  &#xD;
            -  There will be no limitations on number of prior lines of therapy&#xD;
  &#xD;
            -  Trial is open to non-English speaking patients&#xD;
  &#xD;
            -  Trial is open to patients referred from community practice&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are &lt; 18 years old&#xD;
  &#xD;
            -  Patients who are pregnant or breastfeeding (due to cancer of their reproductive&#xD;
               organs, patients enrolled in the trial are unable to conceive)&#xD;
  &#xD;
            -  Patients who are incarcerated&#xD;
  &#xD;
            -  Patients who are unable to provide consent / lack decision-making capacity&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Namita Khanna, MD, MSPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Emory University Hospital/Winship Cancer Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Namita Khanna, MD, MSPH</last_name>
      <phone>404-778-3401</phone>
      <email>namita.khanna@emory.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Emory University Hospital/Winship Cancer Institute</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30322</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Nina Kimball</last_name>
        <phone>404-778-8145</phone>
        <email>nina.cathleen.dobbs.kimball@emory.edu</email>
      </contact>
      <contact_backup>
        <last_name>Maisey S Ratcliffe</last_name>
        <phone>404-778-3449</phone>
        <email>maisey.shannon.ratcliffe@emory.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Namita Khanna, MD, MSPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Emory University</investigator_affiliation>
      <investigator_full_name>Namita Khanna</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cystadenocarcinoma, Serous</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atovaquone</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05998135
  org study id: STUDY00005363
  secondary id: NCI-2023-03479
  secondary id: STUDY00005363
  secondary id: WINSHIP5782-22
  secondary id: P30CA138292
  nct id: NCT05998135
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This phase II trial test tests how well repurposing atovaquone works in treating patients
        with platinum-resistant ovarian cancer. Atovaquone is used for the treatment or prevention of
        certain infections. Atovaquone is in a class of medications called antiprotozoal agents. It
        works by stopping the growth of certain types of protozoa that can cause pneumonia. Giving
        atovaquone may be effective in treating platinum-resistant ovarian cancer and result in
        improved outcomes compared to standard chemotherapy regimens.
  PRIMARY OBJECTIVE:
  
        I. To determine progression free survival of twenty-eight patients with platinum-resistant
        ovarian cancer treated with atovaquone.
  
        SECONDARY OBJECTIVES:
  
        I. To determine clinical benefit rate (complete response, partial response or stable disease)
        at six months.
  
        II. To determine overall survival. III. To quantitate the on-target STAT3 inhibitory effect
        of atovaquone on STAT3-dependent gene transcription.
  
        IV. To quantitate changes of the tumor immune infiltrate by inhibition of STAT3 with
        atovaquone.
  
        OUTLINE:
  
        Patients receive atovaquone orally (PO) on study. Patients also undergo computed tomography
        (CT) and biopsy or paracentesis throughout the study.
  
        After completion of study treatment, patients are followed up for 30 days and then every 6
        month thereafter.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression free survival (PFS)
  time frame: From initiation of atovaquone to progression or death, assessed up to 1 year
  description: Will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.
  measure: Clinical benefit rate
  time frame: At 6 months
  description: Clinical benefit rate is defined as complete response, partial response, and/or stable disease at six months. Clinical response will be assessed every 6 weeks for the first 24 months and every 12 weeks thereafter using Response Evaluation Criteria in Solid Tumors 1.1 criteria. Will be estimated as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method.
  measure: Overall survival (OS)
  time frame: From diagnosis to death from any cause, where patients who are alive will be censored at last follow-up date, assessed up to 1 year
  description: OS will be estimated using the Kaplan-Meier method, and median survival will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach.
  measure: Incidence of adverse events
  time frame: Up to 30 days
  description: Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Frequencies and percentages will be used to summarize safety events.
  arm group label: Treatment (atovaquone)
  arm group type: Experimental
  description: Patients receive atovaquone PO on study. Patients also undergo CT and biopsy or paracentesis throughout the study.
  intervention type: Drug
  intervention name: Atovaquone
  description: Given PO
  arm group label: Treatment (atovaquone)
  other name: 566C80
  other name: BW-566C
  other name: BW-A566C
  other name: Mepron
  intervention type: Procedure
  intervention name: Biopsy
  description: Undergo biopsy
  arm group label: Treatment (atovaquone)
  other name: BIOPSY_TYPE
  other name: Bx
  intervention type: Procedure
  intervention name: Computed Tomography
  description: Undergo CT
  arm group label: Treatment (atovaquone)
  other name: CAT
  other name: CAT Scan
  other name: Computed Axial Tomography
  other name: Computerized Axial Tomography
  other name: Computerized axial tomography (procedure)
  other name: Computerized Tomography
  other name: CT
  other name: CT Scan
  other name: tomography
  intervention type: Procedure
  intervention name: Paracentesis
  description: Undergo paracentesis
  arm group label: Treatment (atovaquone)
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Namita Khanna, MD, MSPH
  role: Principal Investigator
  affiliation: Emory University Hospital/Winship Cancer Institute
  last name: Namita Khanna, MD, MSPH
  phone: 404-778-3401
  email: namita.khanna@emory.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Emory University
  investigator full name: Namita Khanna
  investigator title: Principal Investigator
  mesh term: Cystadenocarcinoma, Serous
  mesh term: Atovaquone