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/NCT05999968</url>
    </required_header>
    <id_info>
      <org_study_id>18714</org_study_id>
      <secondary_id>I3Y-MC-JPEI</secondary_id>
      <secondary_id>2023-503919-15-00</secondary_id>
      <secondary_id>U1111-1294-1466</secondary_id>
      <nct_id>NCT05999968</nct_id>
    </id_info>
    <brief_title>Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment</brief_title>
    <official_title>A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eli Lilly and Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eli Lilly and Company</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>
        The main purpose of this study is to learn more about the safety and tolerability of&#xD;
        abemaciclib when given in combination with darolutamide to participants with prostate cancer&#xD;
        that has spread after initial treatment. Participation may last up to 32 months.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 9, 2024</start_date>
    <completion_date type="Anticipated">July 27, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 27, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>Yes</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>Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</measure>
      <time_frame>Date of first dose to study completion (approximately 32 months)</time_frame>
      <description>Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator</measure>
      <time_frame>Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)</time_frame>
      <description>rPFS Assessed by Investigator</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)</measure>
      <time_frame>Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)</time_frame>
      <description>ORR: Percentage of Participants with Soft Tissue BOR of CR or PR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DoR)</measure>
      <time_frame>Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)</time_frame>
      <description>DOR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Prostate Specific Antigen (PSA) Progression</measure>
      <time_frame>Date of first dose to the first observation of PSA progression (approximately 32 months)</time_frame>
      <description>Time to PSA progression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline</measure>
      <time_frame>Date of first dose to confirmed PSA progression (approximately 32 months)</time_frame>
      <description>PSA-RR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)</measure>
      <time_frame>Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)</time_frame>
      <description>PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite</measure>
      <time_frame>Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)</time_frame>
      <description>PK: Mean Concentrations of Darolutamide and its Active Metabolite</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Prostatic Neoplasms</condition>
    <arm_group>
      <arm_group_label>Abemaciclib + Darolutamide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Abemaciclib</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Abemaciclib + Darolutamide</arm_group_label>
      <other_name>LY2835219</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Darolutamide</intervention_name>
      <description>Administered orally.</description>
      <arm_group_label>Abemaciclib + Darolutamide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LHRH agonist/antagonist</intervention_name>
      <description>Physician's choice. Administered in accordance with the prescribing information.</description>
      <arm_group_label>Abemaciclib + Darolutamide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically confirmed adenocarcinoma of the prostate.&#xD;
  &#xD;
            -  Metastatic castration-resistant prostate cancer evidenced by:&#xD;
  &#xD;
                 -  Prostate-specific antigen (PSA) or radiographic progression despite castrate&#xD;
                    levels of testosterone&#xD;
  &#xD;
                 -  At least 1 bone metastasis on bone scan and/or 1 soft tissue metastasis on&#xD;
                    computed tomography/magnetic resonance imaging (CT/MRI)&#xD;
  &#xD;
            -  Participants who have not undergone bilateral orchiectomy must continue&#xD;
               luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists throughout the&#xD;
               study.&#xD;
  &#xD;
            -  Have adequate organ function.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior treatment with cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitors or&#xD;
               darolutamide.&#xD;
  &#xD;
            -  Prior systemic therapy for metastatic castration-resistant prostate cancer(mCRPC) with&#xD;
               cytotoxic chemotherapy, PARP inhibitors, novel hormonal agents (NHAs) (enzalutamide,&#xD;
               apalutamide, and abiraterone), and radiopharmaceuticals.&#xD;
  &#xD;
            -  Serious preexisting medical condition(s) that, in the judgment of the investigator,&#xD;
               would preclude participation in this study.&#xD;
  &#xD;
            -  Clinically significant heart disease as evidenced by myocardial infarction, arterial&#xD;
               thrombotic events, severe or unstable angina, or congestive heart failure (New York&#xD;
               Heart Association Class III or IV) within 6 months of assignment to treatment.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
      <role>Study Director</role>
      <affiliation>Eli Lilly and Company</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or</last_name>
      <phone>1-317-615-4559</phone>
      <email>ClinicalTrials.gov@Lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Perlmutter Cancer Center at NYU Langone Hospital - Long Island</name>
        <address>
          <city>Mineola</city>
          <state>New York</state>
          <zip>11501</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>212-731-6366</phone>
      </contact>
      <investigator>
        <last_name>David R Wise</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Perlmutter Cancer Center at NYU Langone Hospital - Long Island</name>
        <address>
          <city>Mineola</city>
          <state>New York</state>
          <zip>11501</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>David R Wise</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Laura and Isaac Perlmutter Cancer Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <phone>212-731-6366</phone>
      </contact>
      <investigator>
        <last_name>David R Wise</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Laura and Isaac Perlmutter Cancer Center</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10016</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>David R Wise</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Studienpraxis Urologie</name>
        <address>
          <city>Nürtingen</city>
          <state>Baden-Württemberg</state>
          <zip>72622</zip>
          <country>Germany</country>
        </address>
      </facility>
      <investigator>
        <last_name>Tilman Todenhöfer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Studienpraxis Urologie</name>
        <address>
          <city>Nürtingen</city>
          <state>Baden-Württemberg</state>
          <zip>72622</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <phone>4915201622246</phone>
      </contact>
      <investigator>
        <last_name>Tilman Todenhöfer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Urologische Klinik und Poliklinik</name>
        <address>
          <city>Munich</city>
          <state>Bayern</state>
          <zip>81675</zip>
          <country>Germany</country>
        </address>
      </facility>
      <investigator>
        <last_name>Margitta Retz</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Klinik für Urologie</name>
        <address>
          <city>Lübeck</city>
          <state>Schleswig-Holstein</state>
          <zip>23538</zip>
          <country>Germany</country>
        </address>
      </facility>
      <investigator>
        <last_name>Axel Merseburger</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Onkologisches Zentrum</name>
        <address>
          <city>Hamburg</city>
          <zip>20246</zip>
          <country>Germany</country>
        </address>
      </facility>
      <investigator>
        <last_name>Gunhild Von Amsberg</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical Oncology</name>
        <address>
          <city>Hospitalet</city>
          <state>Barcelona [Barcelona]</state>
          <zip>08907</zip>
          <country>Spain</country>
        </address>
      </facility>
      <investigator>
        <last_name>Josep Maria Piulats Rodriguez</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Oncology</name>
        <address>
          <city>Madrid</city>
          <state>Madrid, Comunidad De</state>
          <zip>28009</zip>
          <country>Spain</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jose Angel Arranz Arija</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical Oncology</name>
        <address>
          <city>Madrid</city>
          <state>Madrid, Comunidad De</state>
          <zip>28034</zip>
          <country>Spain</country>
        </address>
      </facility>
      <investigator>
        <last_name>Teresa Alonso Gordoa</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical Oncology</name>
        <address>
          <city>Madrid</city>
          <state>Madrid, Comunidad De</state>
          <zip>28041</zip>
          <country>Spain</country>
        </address>
      </facility>
      <investigator>
        <last_name>Daniel Castellano Gauna</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Oncología Médica</name>
        <address>
          <city>Badajoz</city>
          <zip>06006</zip>
          <country>Spain</country>
        </address>
      </facility>
      <investigator>
        <last_name>Marta Gonzalez Cordero</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical Oncology</name>
        <address>
          <city>Sevilla</city>
          <zip>41013</zip>
          <country>Spain</country>
        </address>
      </facility>
      <investigator>
        <last_name>JULIA Martinez Perez</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
      <country>Spain</country>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://trials.lilly.com/en-US/trial/418175</url>
      <description>Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment</description>
    </link>
    <verification_date>August 1, 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05999968
  org study id: 18714
  secondary id: I3Y-MC-JPEI
  secondary id: 2023-503919-15-00
  secondary id: U1111-1294-1466
  nct id: NCT05999968
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The main purpose of this study is to learn more about the safety and tolerability of
        abemaciclib when given in combination with darolutamide to participants with prostate cancer
        that has spread after initial treatment. Participation may last up to 32 months.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
  time frame: Date of first dose to study completion (approximately 32 months)
  description: Administration Number of Participants with One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
  measure: Radiographic Progression-Free Survival (rPFS) Assessed by Investigator rPFS Assessed by Investigator
  time frame: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
  description: rPFS Assessed by Investigator
  measure: Objective Response Rate (ORR): Percentage of Participants with Soft Tissue Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
  time frame: Date of first dose to radiographic disease progression or death from any cause (approximately 32 months)
  description: ORR: Percentage of Participants with Soft Tissue BOR of CR or PR
  measure: Duration of Response (DoR)
  time frame: Date of first documented CR or PR to radiographic disease progression or death from any cause (approximately 32 months)
  description: DOR
  measure: Time to Prostate Specific Antigen (PSA) Progression
  time frame: Date of first dose to the first observation of PSA progression (approximately 32 months)
  description: Time to PSA progression
  measure: Prostate Specific Antigen (PSA) Response Rate (PSA-RR): Percentage of Participants with a PSA Decrease of at Least 50% from Baseline
  time frame: Date of first dose to confirmed PSA progression (approximately 32 months)
  description: PSA-RR
  measure: Pharmacokinetics (PK): Mean Concentrations of Abemaciclib and its Active Metabolite(s)
  time frame: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
  description: PK: Mean Concentrations of Abemaciclib and its Active Metabolite(s)
  measure: Pharmacokinetics (PK): Mean Concentrations of Darolutamide and its Active Metabolite
  time frame: Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle = 28 days)
  description: PK: Mean Concentrations of Darolutamide and its Active Metabolite
  arm group label: Abemaciclib + Darolutamide
  arm group type: Experimental
  description: Abemaciclib plus (+) darolutamide. Participants who have not undergone bilateral orchiectomy are required to continue background androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist/antagonist throughout the study.
  intervention type: Drug
  intervention name: Abemaciclib
  description: Administered orally.
  arm group label: Abemaciclib + Darolutamide
  other name: LY2835219
  intervention type: Drug
  intervention name: Darolutamide
  description: Administered orally.
  arm group label: Abemaciclib + Darolutamide
  intervention type: Drug
  intervention name: LHRH agonist/antagonist
  description: Physician's choice. Administered in accordance with the prescribing information.
  arm group label: Abemaciclib + Darolutamide
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
  role: Study Director
  affiliation: Eli Lilly and Company
  last name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  phone: 1-317-615-4559
  email: ClinicalTrials.gov@Lilly.com
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  country: Germany
  country: Spain
  country: United States
  url: https://trials.lilly.com/en-US/trial/418175
  description: Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: No