<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/NCT03291886</url>
  </required_header>
  <id_info>
    <org_study_id>2375-002</org_study_id>
    <nct_id>NCT03291886</nct_id>
  </id_info>
  <brief_title>Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer</brief_title>
  <official_title>Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyowa Kirin Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyowa Kirin Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The primary objective of this study is to investigate the effect of 5 mg KHK2375 on&#xD;
      progression free survival (PFS) when administered orally at weekly intervals in combination&#xD;
      with exemestane in a placebo-controlled, double-blind comparative study in subjects with&#xD;
      advanced or recurrent hormone receptor-positive breast cancer. The secondary objectives are&#xD;
      to investigate the effect of on overall survival (OS) and the antitumor effect and to&#xD;
      evaluate the pharmacokinetics and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 22, 2017</start_date>
  <completion_date type="Actual">March 26, 2021</completion_date>
  <primary_completion_date type="Actual">April 4, 2019</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>Double-blinded, randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival(PFS) defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1)</measure>
    <time_frame>Approximately 29 months</time_frame>
    <description>PFS is defined as the number of days from the date of randomization to the date of first documented progressive disease (PD) or the date of death from any cause, whichever comes first (date of first documented PD or death - date of randomization + 1). The date of first documented PD is the date when PD is first documented at overall response assessment or the date when overall response other than complete response (CR) and not evaluable (NE) is documented after first CR. Subjects who receive post-study treatment before the documentation of PD and subjects with no documented PD or death will be censored at the last date they were confirmed to have no PD. Subjects whose overall response from the date of randomization onward is only NE or who have never undergone assessment of antitumor effect, and whose death has not been documented will be censored at the date of randomization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up to 50 months</time_frame>
    <description>OS is defined as the number of days from the date of randomization to death from any cause (date of death - date of randomization + 1). Subjects without documented death at the time of data cutoff will be censored at the last date they were confirmed to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antitumor effect</measure>
    <time_frame>Up to 50 months</time_frame>
    <description>The best overall response is defined as the best response recorded from the start of treatment until progression or recurrence according to the categories ordered as CR &gt; partial response(PR) &gt; stable disease (SD) &gt; PD &gt; NE or CR &gt; Non-CR/non-PD &gt; PD &gt; NE. A best overall response of CR or PR will be regarded as objective response. A best overall response of CR, PR, or SD for at least 6 months will be regarded as clinical benefit.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Plasma concentration of KHK2375</measure>
    <time_frame>Day 1 of Cycle 1, Day 15 of Cycle 1 , and Day 1 of Cycle 2 (each cycle is 28 days)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of subjects with treatment-emergent adverse events</measure>
    <time_frame>Assessed up to 28 days after study discontinuation</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Advanced or Recurrent Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Arm A (exemestane, Entinostat)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg KHK2375 will be administered to subjects once weekly. EXE001 will be administered at a dose of 25 mg once daily orally.&#xD;
Pre/perimenopausal female patients also receive luteinizing hormone-releasing hormone (LH-RH) agonist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (exemestane, Entinostat(placebo))</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>KHK2375 Placebo will be administered to subjects once weekly. EXE001 will be administered at a dose of 25 mg once daily orally.&#xD;
Pre/perimenopausal female patients also receive luteinizing hormone-releasing hormone (LH-RH) agonist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Entinostat</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm A (exemestane, Entinostat)</arm_group_label>
    <other_name>KHK2375</other_name>
    <other_name>MS-275</other_name>
    <other_name>SNDX-275</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Entinostat(Placebo)</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm B (exemestane, Entinostat(placebo))</arm_group_label>
    <other_name>KHK2375</other_name>
    <other_name>MS-275</other_name>
    <other_name>SNDX-275</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exemestane</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm A (exemestane, Entinostat)</arm_group_label>
    <arm_group_label>Arm B (exemestane, Entinostat(placebo))</arm_group_label>
    <other_name>EXE001</other_name>
    <other_name>Aromasin</other_name>
    <other_name>FCE-24304</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Personally submitted voluntary written informed consent to participate in the study&#xD;
&#xD;
          2. Age ≥ 20 years at the time of consent&#xD;
&#xD;
          3. Histologically or cytologically confirmed breast cancer positive for estrogen receptor&#xD;
             (ER) and/or progesterone receptor (PgR)&#xD;
&#xD;
          4. Human epidermal growth factor 2 (HER2)-negative&#xD;
&#xD;
          5. Stage III/locally advanced or metastatic carcinoma of the breast where local therapy&#xD;
             with curative intent is impossible&#xD;
&#xD;
          6. Pre/Peri- and postmenopausal women&#xD;
&#xD;
               -  Postmenopausal status is defined either by:&#xD;
&#xD;
                    1. Age ≥ 55 years and ≥ 1 year of amenorrhea&#xD;
&#xD;
                    2. Age &lt; 55 years and ≥ 1 year of amenorrhea, with blood estradiol (E2) &lt; 20&#xD;
                       pg/mL&#xD;
&#xD;
                    3. Age &lt; 55 years with hysterectomy, with ovaries and E2 &lt; 20 pg/mL&#xD;
&#xD;
               -  Surgical menopause with bilateral oophorectomy Pre/perimenopausal women may be&#xD;
                  enrolled only if they agree to receive an luteinizing hormone-releasing hormone&#xD;
                  (LH-RH) agonist&#xD;
&#xD;
          7. Eastern Cooperative Oncology Group(ECOG) performance status (PS) of 0 or 1 at&#xD;
             enrollment&#xD;
&#xD;
          8. Measurable or nonmeasurable lesions per RECIST version 1.1 criteria&#xD;
&#xD;
          9. Subjects meeting either of the following criteria:&#xD;
&#xD;
               -  History of treatment with a nonsteroidal aromatase inhibitor (AI) for advanced or&#xD;
                  recurrent breast cancer, and development of progressive disease (PD) after the&#xD;
                  most recent prior treatment&#xD;
&#xD;
               -  No history of treatment with endocrine therapy for advanced or recurrent breast&#xD;
                  cancer that has recurred during or within 12 months after postoperative adjuvant&#xD;
                  therapy with an nonsteroidal AI&#xD;
&#xD;
         10. An adverse event for which a causal relationship to prior treatment cannot be denied&#xD;
             (except alopecia) is Grade ≤ 1 in severity or has returned to the baseline level,&#xD;
             i.e., the level before the start of the prior treatment&#xD;
&#xD;
         11. The latest laboratory values obtained prior to enrollment must meet all of the&#xD;
             following requirements:&#xD;
&#xD;
               -  Hemoglobin concentration: ≥ 9.0 g/dL&#xD;
&#xD;
               -  Platelet count: ≥ 100000/μL&#xD;
&#xD;
               -  Neutrophil count: ≥ 1500/μL&#xD;
&#xD;
               -  Serum creatinine: ≤ 2.0 mg/dL&#xD;
&#xD;
               -  Total bilirubin in serum: &lt; 1.5 × institutional upper limit of normal (≤ 3 mg/dL&#xD;
                  for subjects with Gilbert's syndrome)&#xD;
&#xD;
               -  Aspartate transaminase(AST) and Alanine transaminase(ALT): ≤ 3.0 × institutional&#xD;
                  upper limit of normal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Endocrine therapy (except for LH-RH agonist), treatment with everolimus, treatment&#xD;
             with a cyclin-dependent kinase inhibitor, or radiation therapy within 14 days before&#xD;
             enrollment&#xD;
&#xD;
             Subjects with prior treatment with exemestane may be enrolled if they meet either of&#xD;
             the following criteria:&#xD;
&#xD;
               -  Start of treatment with exemestane for advanced or recurrent breast cancer within&#xD;
                  28 days before enrollment&#xD;
&#xD;
               -  Recurrence-free period &gt;12 months after completion of treatment with exemestane&#xD;
                  as postoperative adjuvant therapy. For painful bone lesions or impending&#xD;
                  fractures, radiation therapy may be used concomitantly if there is a measurable&#xD;
                  or nonmeasurable lesion that is suitable for efficacy evaluation in a region&#xD;
                  other than the radiation field&#xD;
&#xD;
          2. Two or more prior chemotherapy regimens for advanced or recurrent breast cancer&#xD;
&#xD;
          3. Chemotherapy within 21 days before enrollment&#xD;
&#xD;
          4. Treatment with bisphosphonates or anti-RANKL antibody that is scheduled to be started&#xD;
             within 7 days before the first dose of investigational product&#xD;
&#xD;
          5. History of or current central nervous system metastasis, or current leptomeningeal or&#xD;
             periosteal disease&#xD;
&#xD;
          6. History of cancer other than breast cancer within 5 years, or concurrent cancer other&#xD;
             than breast cancer (except for basal cell carcinoma of skin, squamous cell carcinoma&#xD;
             of skin, and intraepithelial carcinoma of uterine cervix).Subjects continuing to&#xD;
             receive treatment for cancer other than breast cancer are ineligible for enrollment&#xD;
&#xD;
          7. Ongoing treatment with any other anticancer therapy or investigational product (Except&#xD;
             for treatment with exemestane or radiotherapy as described in exclusion criterion 1)&#xD;
&#xD;
          8. Prior treatment with histone deacetylase inhibitor (e.g. valproate, vorinostat)&#xD;
&#xD;
          9. Known allergy to imidazoles, exemestane, or entinostat&#xD;
&#xD;
         10. Any medical or psychiatric condition that could affect compliance with the protocol,&#xD;
             ability to give consent, or assessment of anticipated toxicities&#xD;
&#xD;
         11. Uncontrolled complications (e.g., active infections)&#xD;
&#xD;
         12. Positive for either hepatitis B surface antigen, hepatitis C virus antibody, or human&#xD;
             immunodeficiency virus antibody&#xD;
&#xD;
         13. Any other conditions unsuitable for the study in the opinion of the investigator or&#xD;
             subinvestigator&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitakyushu Municipal Medical Center</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma Cancer Center</name>
      <address>
        <city>Ota</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Cancer Center</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital of Hyogo College of Medicine</name>
      <address>
        <city>Nishinomiya</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tsukuba University Hospital</name>
      <address>
        <city>Tsukuba</city>
        <state>Ibaraki</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Isehara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nahanishi Clinic</name>
      <address>
        <city>Naha</city>
        <state>Okinawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center</name>
      <address>
        <city>Hidaka</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital</name>
      <address>
        <city>Bunkyo</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Koto</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital</name>
      <address>
        <city>Minato</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University Hospital</name>
      <address>
        <city>Shinagawa</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sagara Hospital</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kumamoto University Hospital</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata Cancer Center Hospital</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka National Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>June 15, 2022</last_update_submitted>
  <last_update_submitted_qc>June 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</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>Breast Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Exemestane</mesh_term>
    <mesh_term>Entinostat</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/NCT03291886
org study id: 2375-002
nct id: NCT03291886
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to investigate the effect of 5 mg KHK2375 on
      progression free survival (PFS) when administered orally at weekly intervals in combination
      with exemestane in a placebo-controlled, double-blind comparative study in subjects with
      advanced or recurrent hormone receptor-positive breast cancer. The secondary objectives are
      to investigate the effect of on overall survival (OS) and the antitumor effect and to
      evaluate the pharmacokinetics and safety.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double-blinded, randomized trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Progression Free Survival(PFS) defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1)
time frame: Approximately 29 months
description: PFS is defined as the number of days from the date of randomization to the date of first documented progressive disease (PD) or the date of death from any cause, whichever comes first (date of first documented PD or death - date of randomization + 1). The date of first documented PD is the date when PD is first documented at overall response assessment or the date when overall response other than complete response (CR) and not evaluable (NE) is documented after first CR. Subjects who receive post-study treatment before the documentation of PD and subjects with no documented PD or death will be censored at the last date they were confirmed to have no PD. Subjects whose overall response from the date of randomization onward is only NE or who have never undergone assessment of antitumor effect, and whose death has not been documented will be censored at the date of randomization.
measure: Overall survival (OS)
time frame: Up to 50 months
description: OS is defined as the number of days from the date of randomization to death from any cause (date of death - date of randomization + 1). Subjects without documented death at the time of data cutoff will be censored at the last date they were confirmed to be alive.
measure: Antitumor effect
time frame: Up to 50 months
description: The best overall response is defined as the best response recorded from the start of treatment until progression or recurrence according to the categories ordered as CR > partial response(PR) > stable disease (SD) > PD > NE or CR > Non-CR/non-PD > PD > NE. A best overall response of CR or PR will be regarded as objective response. A best overall response of CR, PR, or SD for at least 6 months will be regarded as clinical benefit.
measure: Plasma concentration of KHK2375
time frame: Day 1 of Cycle 1, Day 15 of Cycle 1 , and Day 1 of Cycle 2 (each cycle is 28 days)
measure: Frequency of subjects with treatment-emergent adverse events
time frame: Assessed up to 28 days after study discontinuation
arm group label: Arm A (exemestane, Entinostat)
arm group type: Experimental
description: 5 mg KHK2375 will be administered to subjects once weekly. EXE001 will be administered at a dose of 25 mg once daily orally.
Pre/perimenopausal female patients also receive luteinizing hormone-releasing hormone (LH-RH) agonist.
arm group label: Arm B (exemestane, Entinostat(placebo))
arm group type: Placebo Comparator
description: KHK2375 Placebo will be administered to subjects once weekly. EXE001 will be administered at a dose of 25 mg once daily orally.
Pre/perimenopausal female patients also receive luteinizing hormone-releasing hormone (LH-RH) agonist.
intervention type: Drug
intervention name: Entinostat
description: Given PO
arm group label: Arm A (exemestane, Entinostat)
other name: KHK2375
other name: MS-275
other name: SNDX-275
intervention type: Drug
intervention name: Entinostat(Placebo)
description: Given PO
arm group label: Arm B (exemestane, Entinostat(placebo))
other name: KHK2375
other name: MS-275
other name: SNDX-275
intervention type: Drug
intervention name: Exemestane
description: Given PO
arm group label: Arm A (exemestane, Entinostat)
arm group label: Arm B (exemestane, Entinostat(placebo))
other name: EXE001
other name: Aromasin
other name: FCE-24304
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
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country: Japan
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Recurrence
mesh term: Exemestane
mesh term: Entinostat
sharing ipd: No