<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/NCT03285802</url>
  </required_header>
  <id_info>
    <org_study_id>CRAD001X2401</org_study_id>
    <nct_id>NCT03285802</nct_id>
  </id_info>
  <brief_title>Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation</brief_title>
  <official_title>CRAD001X2401: Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Greater Baltimore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Greater Baltimore Medical Center</source>
  <oversight_info>
    <has_dmc>No</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 an open-label treatment program following basic prescribing information for patients&#xD;
      with recurrent UPSC (Uterine Papillary Serous Carcinoma) to provide access to everolimus and&#xD;
      limited treatment alternatives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective is to provide access to everolimus for patients with Recurrent UPSC and limited&#xD;
      treatment alternatives.&#xD;
&#xD;
      Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">February 12, 2019</completion_date>
  <primary_completion_date type="Actual">February 12, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <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>Single Arm Trial With Combination of Everolimus and Letrozole in Treatment With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation; Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria</measure>
    <time_frame>Baseline, Then every 12 weeks while on Everolimus and Letrozole up to 36 months;</time_frame>
    <description>Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single Arm Trial With Combination of Everolimus and Letrozole in Treatment With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation; Overall survival of patients treated with the combination of letrozole and everolimus</measure>
    <time_frame>From randomization until date of death, assessed up to 36 months</time_frame>
    <description>Overall survival of patients treated with the combination of letrozole and everolimus</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Uterine Cancer</condition>
  <arm_group>
    <arm_group_label>Letrozole and Everolimus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Letrozole</intervention_name>
    <description>Letrozole 2.5mg will be taken daily q 30 days</description>
    <arm_group_label>Letrozole and Everolimus</arm_group_label>
    <other_name>Femara</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Everolimus</intervention_name>
    <description>Everolimus 10mg daily q 28 days</description>
    <arm_group_label>Letrozole and Everolimus</arm_group_label>
    <other_name>Afinitor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient has adequate bone marrow and coagulation function as shown by: absolute&#xD;
             neutrophil count (ANC) ≥ 1.5 × 109/L; platelets ≥ 100 × 109/L; hemoglobin (Hgb) ≥ 9.0&#xD;
             g/dL.&#xD;
&#xD;
          2. Patient has adequate liver function as shown by:&#xD;
&#xD;
               1. total serum bilirubin ≤2.0 mg/dL,&#xD;
&#xD;
               2. ALT and AST ≤2.5x ULN (≤5x ULN in patients with liver metastases),&#xD;
&#xD;
               3. INR ≤2;.&#xD;
&#xD;
          3. Patient has adequate renal function as shown by serum creatinine ≤ 1.5 × ULN.&#xD;
&#xD;
          4. Patient has fasting serum cholesterol ≤ 300mg/dl or 7.75mmol/L AND fasting&#xD;
             triglycerides ≤ 2.5 × ULN. NOTE: In case one or both of these thresholds are exceeded,&#xD;
             the patient can only be included after initiation of appropriate lipid lowering&#xD;
             medication.&#xD;
&#xD;
          5. Patient will give a written informed consent obtained according to local guidelines.&#xD;
&#xD;
          6. Sexually active males must use a condom during intercourse while taking everolimus for&#xD;
             treatment, for 8 weeks after stopping treatment, or their female partners should use&#xD;
             highly effective contraception during this specified time period.&#xD;
&#xD;
          7. Women of childbearing potential must have had a negative serum pregnancy test 14 days&#xD;
             prior to the start of everolimus treatment plus a negative local urine pregnancy test&#xD;
             prior to treatment and must be willing to use highly effective methods of&#xD;
             contraception during the study and for 8 weeks after study drug administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has had prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus,&#xD;
             deforolimus).&#xD;
&#xD;
          2. Patient has a known intolerance or hypersensitivity to everolimus or other rapamycin&#xD;
             analogs (e.g. sirolimus, temsirolimus).&#xD;
&#xD;
          3. Patient has uncontrolled diabetes mellitus as defined by fasting serum glucose &gt; 1.5 ×&#xD;
             ULN despite adequate therapy. Patients with a known history of impaired fasting&#xD;
             glucose or diabetes mellitus (DM) may be included, however blood glucose and&#xD;
             antidiabetic treatment must be monitored closely throughout participation in the&#xD;
             program and adjusted as necessary.&#xD;
&#xD;
          4. Patient has any severe and/or uncontrolled medical conditions such as:&#xD;
&#xD;
               1. unstable angina pectoris, symptomatic congestive heart failure, myocardial&#xD;
                  infarction ≤6 months prior to randomization, serious uncontrolled cardiac&#xD;
                  arrhythmia,&#xD;
&#xD;
               2. active or uncontrolled severe infection,&#xD;
&#xD;
               3. liver disease such as cirrhosis, decompensated liver disease, and chronic&#xD;
                  hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable&#xD;
                  HCV-RNA),&#xD;
&#xD;
               4. known severely impaired lung function (spirometry and DLCO 50% or less of normal&#xD;
                  and O2 saturation 88% or less at rest on room air),&#xD;
&#xD;
               5. active, bleeding diathesis.&#xD;
&#xD;
          5. Chronic treatment with corticosteroids or other immunosuppressive agents.&#xD;
&#xD;
          6. Patient has a known history of HIV seropositivity.&#xD;
&#xD;
          7. Patient is a woman of child-bearing potential, unless she is using highly effective&#xD;
             contraception methods.&#xD;
&#xD;
               -  Women of child-bearing potential (WOCBP) is defined as all women physiologically&#xD;
                  capable of becoming pregnant, including women whose career, lifestyle, or sexual&#xD;
                  orientation precludes intercourse with a male partner and women whose partner has&#xD;
                  been sterilized by vasectomy or other means.&#xD;
&#xD;
               -  Highly effective contraception, defined as one that results in an annual&#xD;
                  pregnancy rate &lt;1% when used correctly, comprises one of the following methods:&#xD;
&#xD;
               -  Total abstinence (when this is in line with the preferred and usual lifestyle of&#xD;
                  the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal,&#xD;
                  post-ovulation methods) and withdrawal are not acceptable methods of&#xD;
                  contraception)&#xD;
&#xD;
               -  Male/female sterilization&#xD;
&#xD;
               -  Use of oral, injected or implanted hormonal methods of contraception or placement&#xD;
                  of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of&#xD;
                  hormonal contraception that have comparable efficacy (failure rate &lt;1%), for&#xD;
                  example hormone vaginal ring or transdermal hormone contraception&#xD;
&#xD;
          8. Patient is unwilling to or unable to comply with the treatment plan.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Greater Baltimore Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Greater Baltimore Medical Center</investigator_affiliation>
    <investigator_full_name>Melissa Loomis, CCRP</investigator_full_name>
    <investigator_title>Gynecologic Oncologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Neoplasms</mesh_term>
    <mesh_term>Cystadenocarcinoma, Serous</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</mesh_term>
    <mesh_term>Letrozole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03285802
org study id: CRAD001X2401
nct id: NCT03285802
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label treatment program following basic prescribing information for patients
      with recurrent UPSC (Uterine Papillary Serous Carcinoma) to provide access to everolimus and
      limited treatment alternatives.
The objective is to provide access to everolimus for patients with Recurrent UPSC and limited
      treatment alternatives.

      Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Single Arm Trial With Combination of Everolimus and Letrozole in Treatment With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation; Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria
time frame: Baseline, Then every 12 weeks while on Everolimus and Letrozole up to 36 months;
description: Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria
measure: Single Arm Trial With Combination of Everolimus and Letrozole in Treatment With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation; Overall survival of patients treated with the combination of letrozole and everolimus
time frame: From randomization until date of death, assessed up to 36 months
description: Overall survival of patients treated with the combination of letrozole and everolimus
arm group label: Letrozole and Everolimus
arm group type: Experimental
description: Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days
intervention type: Drug
intervention name: Letrozole
description: Letrozole 2.5mg will be taken daily q 30 days
arm group label: Letrozole and Everolimus
other name: Femara
intervention type: Drug
intervention name: Everolimus
description: Everolimus 10mg daily q 28 days
arm group label: Letrozole and Everolimus
other name: Afinitor
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Greater Baltimore Medical Center
investigator full name: Melissa Loomis, CCRP
investigator title: Gynecologic Oncologist
mesh term: Uterine Neoplasms
mesh term: Cystadenocarcinoma, Serous
mesh term: Everolimus
mesh term: Letrozole
sharing ipd: Undecided