<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/NCT04457089</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2020-03-Rimel-STOV</org_study_id>
    <nct_id>NCT04457089</nct_id>
  </id_info>
  <brief_title>Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer</brief_title>
  <official_title>Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bobbie Jo Rimel, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</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 is a single arm pilot trial to evaluate the feasibility of using a simvastatin&#xD;
      intervention, and to evaluate its effects on cancer progression, among 20 patients with&#xD;
      platinum-sensitive ovarian cancer, treated with carboplatin and liposomal doxorubicin at&#xD;
      Cedars-Sinai Medical Center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study of statin therapy to examine the feasibility of simvastatin use to&#xD;
      reduce disease progression in 20 patients with platinum-sensitive ovarian cancer at&#xD;
      Cedars-Sinai Medical Center. This study will focus on patients with recurrent platinum&#xD;
      sensitive ovarian cancer to increase the likelihood that this population will experience&#xD;
      recurrent disease during the 6-month intervention and follow-up. In addition, this population&#xD;
      of patients has a narrow range of standard of care carboplatin doublet combinations that are&#xD;
      prescribed, enabling the investigators to create a more homogenous study population. Given&#xD;
      their high risk of developing recurrent disease, women with platinum sensitive ovarian&#xD;
      cancer, have the potential to derive the maximum benefit from an intervention that could&#xD;
      delay disease progression and enhance survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 25, 2021</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Early 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>Completion of the simvastatin intervention with at least 85% compliance</measure>
    <time_frame>From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days)</time_frame>
    <description>Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response by CA125</measure>
    <time_frame>From baseline until 12 months</time_frame>
    <description>Change in serum level of CA125</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>From baseline until 12 months</time_frame>
    <description>Duration until disease progression or death</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Recurrent Ovarian Cancer</condition>
  <condition>Platinum-sensitive Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Simvastatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simvastatin 40mg</intervention_name>
    <description>Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin</description>
    <arm_group_label>Simvastatin</arm_group_label>
    <other_name>Zocor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recurrent platinum sensitive ovarian cancer, all histologies (serous, endometrioid,&#xD;
             mucinous, clear cell). Platinum sensitivity defined as ≥ 6 months since last platinum&#xD;
             treatment.&#xD;
&#xD;
          -  No contraindication to carboplatin and/or liposomal doxorubicin or simvastatin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior or current use of any statin medication&#xD;
&#xD;
          -  Current systemic use of medications known to interact with statins&#xD;
&#xD;
          -  Current use of any other investigational agents&#xD;
&#xD;
          -  Liver disease, active cirrhosis&#xD;
&#xD;
          -  Uncontrolled intercurrent illness&#xD;
&#xD;
          -  History of chronic myopathy&#xD;
&#xD;
          -  Prior cancer other than ovarian cancer or non-melanomatous skin cancers&#xD;
&#xD;
          -  Known active infection with HIV&#xD;
&#xD;
          -  Current excessive alcohol consumption (average alcohol consumption of more than 5&#xD;
             drinks per day)&#xD;
&#xD;
          -  Prior exposure to doxorubicin or liposomal doxorubicin&#xD;
&#xD;
          -  Hemoglobin A1C &gt;8.0%&#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>Bobbie Jo Rimel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amy Oppenheim</last_name>
    <phone>310-423-2133</phone>
    <email>cancer.trial.info@cshs.org</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Cynthia Martin</last_name>
      <phone>310-423-2276</phone>
      <email>Cynthia.Martin@cshs.org</email>
    </contact>
    <investigator>
      <last_name>Bobbie Jo Rimel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marc Goodman, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Li, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christine Walsh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kristin Taylor, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 14, 2023</last_update_submitted>
  <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Bobbie Jo Rimel, MD</investigator_full_name>
    <investigator_title>Oncologist</investigator_title>
  </responsible_party>
  <keyword>simvastatin</keyword>
  <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>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simvastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04457089
org study id: IIT2020-03-Rimel-STOV
nct id: NCT04457089
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a single arm pilot trial to evaluate the feasibility of using a simvastatin
      intervention, and to evaluate its effects on cancer progression, among 20 patients with
      platinum-sensitive ovarian cancer, treated with carboplatin and liposomal doxorubicin at
      Cedars-Sinai Medical Center.
This is a pilot study of statin therapy to examine the feasibility of simvastatin use to
      reduce disease progression in 20 patients with platinum-sensitive ovarian cancer at
      Cedars-Sinai Medical Center. This study will focus on patients with recurrent platinum
      sensitive ovarian cancer to increase the likelihood that this population will experience
      recurrent disease during the 6-month intervention and follow-up. In addition, this population
      of patients has a narrow range of standard of care carboplatin doublet combinations that are
      prescribed, enabling the investigators to create a more homogenous study population. Given
      their high risk of developing recurrent disease, women with platinum sensitive ovarian
      cancer, have the potential to derive the maximum benefit from an intervention that could
      delay disease progression and enhance survival.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Completion of the simvastatin intervention with at least 85% compliance
time frame: From Cycle 1 Day 1 until Cycle 6 Day 28 (each cycle is 28 days)
description: Percentage of patients who complete the simvastatin intervention with at least 85% compliance during Carboplatin and Doxil chemotherapy.
measure: Response by CA125
time frame: From baseline until 12 months
description: Change in serum level of CA125
measure: Progression-free survival
time frame: From baseline until 12 months
description: Duration until disease progression or death
arm group label: Simvastatin
arm group type: Experimental
intervention type: Drug
intervention name: Simvastatin 40mg
description: Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin
arm group label: Simvastatin
other name: Zocor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bobbie Jo Rimel, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Amy Oppenheim
phone: 310-423-2133
email: cancer.trial.info@cshs.org
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Bobbie Jo Rimel, MD
investigator title: Oncologist
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Hypersensitivity
mesh term: Simvastatin
sharing ipd: No