<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/NCT02204072</url>
  </required_header>
  <id_info>
    <org_study_id>1280.8</org_study_id>
    <secondary_id>2013-004011-41</secondary_id>
    <nct_id>NCT02204072</nct_id>
  </id_info>
  <brief_title>BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)</brief_title>
  <official_title>A Phase Ib/II, Multicentre, Open Label, Randomized Study of BI 836845 in Combination With Enzalutamide, Versus Enzalutamide Alone, in Metastatic Castration-Resistant Prostate Cancer (CRPC) Following Disease Progression on Docetaxel-Based Chemotherapy and Abiraterone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The overall aim of the trial is to investigate the safety and anti-tumour activity of an&#xD;
      experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide,&#xD;
      compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients&#xD;
      that have previously been treated and failed on docetaxel and abiraterone treatments.&#xD;
      Initially, a tolerability and safety phase (phase Ib escalation) will be performed to confirm&#xD;
      the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and enzalutamide&#xD;
      that can be taken together.&#xD;
&#xD;
      Once the MTD, or recommended phase II dose, have been determined an expansion cohort will&#xD;
      also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have a&#xD;
      rise in prostate serum antigen (PSA) levels. Patients may not have received prior docetaxel&#xD;
      or abiraterone. Patients in this cohort will receive the MTD, or recommended phase II dose,&#xD;
      of BI 836845 and enzalutamide determined in the phase Ib escalation phase.&#xD;
&#xD;
      The randomised trial (phase II) will be an open label, parallel group study design in a 1:1&#xD;
      ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the&#xD;
      MTD/recommended doses, or enzalutamide alone (Arm B).&#xD;
&#xD;
      In all parts of the trial safety, anti-tumour activity will be assessed, in addition to&#xD;
      circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and&#xD;
      determination of Overall Survival (OS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2014</start_date>
  <completion_date type="Actual">June 1, 2023</completion_date>
  <primary_completion_date type="Actual">October 18, 2019</primary_completion_date>
  <phase>Phase 1</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with dose limiting toxicities (phase Ib escalation)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum tolerated dose (phase Ib escalation)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Prostate Surface Antigen (PSA) response - defined as a decline in PSA value &gt;50% (which is confirmed by a second value 3 to 4 weeks apart) (phase Ib expansion)</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiological Progression free survival - time from randomisation to disease progression based on investigator assessment in bone, or soft tissue, or death (phase II)</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival - defined as the time from randomisation to death from any cause (phase II)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to prostate serum antigen (PSA) progression - defined as the date that a 25% or greater increase in PSA, and an absolute increase of 2 ng/mL or more from the nadir, is documented, which is confirmed by a second value 3 or more weeks later (phase II)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum decline in PSA - compared to baseline that occurs at any point after treatment start (phase II)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage change in PSA - from baseline to week 12 of treatment (phase II)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CTC response-CTC reduction compared to baseline for at least one time point after treatment start assessed by maximum change in CTC counts compared to baseline that occurs at any point after treatment start (phase II)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological progression free survival - defined as time from start of treatment to disease progression based on investigator assessment in bone based on PCWG2 or soft tissue based on modified RECIST 1.1 where applicable, or death (phase Ib expansion)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CTC response - CTC reduction compared to baseline for at least one time point after treatment start assessed by CTC decline from, equal to, or more than, 5 to &lt;5 cells per 7.5ml blood (phase II)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in circulating tumour cells (CTC) response - CTC reduction compared to baseline for at least one time point after treatment defined as CTC decline from, equal to, or more than, 5 to &lt;5 cells per 7.5ml blood (phase Ib expansion)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PSA response - defined as a decline in PSA value &gt;50%, which is confirmed by a second value 3 to 4 weeks apart (phase II)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological progression free survival - defined as time from randomisation to disease progression based on central review in bone based on PCWG2 or soft tissue based on modified RECIST 1.1 where applicable, or death (phase II)</measure>
    <time_frame>Up to 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Prostatic Neoplasms, Castration-Resistant</condition>
  <arm_group>
    <arm_group_label>BI 836845 &amp; Enzalutamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Enzalutamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 836845</intervention_name>
    <arm_group_label>BI 836845 &amp; Enzalutamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <arm_group_label>Enzalutamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enzalutamide</intervention_name>
    <arm_group_label>BI 836845 &amp; Enzalutamide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  The patient has histologically, or cytologically, confirmed adenocarcinoma of the&#xD;
             prostate.&#xD;
&#xD;
          -  Male patient aged, equal to, or more than,18 years old.&#xD;
&#xD;
          -  Patients with radiographic evidence of metastatic prostate cancer (stage M1 or D2).&#xD;
             Distant metastases evaluable by radionuclide bone scan, CT scan, or MRI within 28 days&#xD;
             before the start of study treatment.&#xD;
&#xD;
          -  Patients with a prostate serum antigen (PSA), equal to, or more than, 5 nanograms per&#xD;
             mililiter (ng/mL).&#xD;
&#xD;
          -  Patients with prior surgical or chemical castration with a serum testosterone of &lt;50&#xD;
             ng/mL. If the method of castration is luteinizing hormone releasing level hormone&#xD;
             (LHRH) agonists, the patient must be willing to continue the use of LHRH agonists&#xD;
             during protocol treatment.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.&#xD;
&#xD;
          -  Cardiac left ventricular function with resting ejection fraction &gt;50% as determined by&#xD;
             echocardiogram (ECHO) or multigated acquisition scan (MUGA).&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;=1500/microlitre (uL).&#xD;
&#xD;
          -  Haemoglobin &gt;=9 gram per deciliter (g/dL).&#xD;
&#xD;
          -  Platelets &gt;=100,000/uL.&#xD;
&#xD;
          -  Bilirubin &lt;= 1.5 times the upper limit of normal (ULN).&#xD;
&#xD;
          -  Aspartate transaminase (AST) and alanine transaminase (ALT) &lt;= 2.5 times the ULN(or &lt;=&#xD;
             5 times the ULN if liver metastases are present).&#xD;
&#xD;
          -  Creatinine &lt;= 1.5 x ULN.&#xD;
&#xD;
          -  International normalized ratio (INR) &lt;/= 2 and a partial thromboplastin time (PTT) &lt;/=&#xD;
             5 seconds above the ULN (unless on oral anticoagulant therapy). Patients receiving&#xD;
             full dose anticoagulation therapy are eligible provided they meet all other criteria,&#xD;
             are on a stable dose of oral anticoagulant or low molecular weight heparin (except&#xD;
             warfarin or coumarin-like anticoagulants, which are not permitted).&#xD;
&#xD;
          -  Fasting plasma glucose &lt; 8.9 millimols per liter (mmol/L) (&lt; 160 milligrams per&#xD;
             deciliter (mg/dL) and glycated haemoglobin (hemoglobin A1c (HbA1c)) &lt; 8.0%.&#xD;
&#xD;
        Inclusion criteria only for patients entering phase Ib escalation and phase II:&#xD;
&#xD;
          -  Patients who have disease progression during, or after, receiving docetaxel and have&#xD;
             had at least 12 weeks of treatment and in the opinion of the investigator are unlikely&#xD;
             to derive significant benefit from additional docetaxel-based therapy, or were&#xD;
             intolerant to therapy with this agent.&#xD;
&#xD;
          -  Patients who have disease progression during, or after, receiving abiraterone&#xD;
             treatment in any setting.&#xD;
&#xD;
          -  Patients must have progressive disease defined as at least one of the following:&#xD;
&#xD;
               1. Progressive measurable disease: using conventional solid tumour criteria RECIST&#xD;
                  1.1.&#xD;
&#xD;
               2. Bone scan progression: at least two new lesions on bone scan, plus a rising PSA&#xD;
                  as described in (c) below.&#xD;
&#xD;
               3. Increasing PSA level: at least two consecutive rising PSA values over a reference&#xD;
                  value (PSA #1) taken at least 1 week apart. A third PSA (PSA #3) is required to&#xD;
                  be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater&#xD;
                  than PSA #2.&#xD;
&#xD;
        Inclusion criterion only for patients entering phase Ib expansion cohort:&#xD;
&#xD;
          -  Patients must be receiving continuous enzalutamide treatment and show a rise in PSA&#xD;
             level: at least two consecutive rising PSA values over a reference value (PSA #1)&#xD;
             taken at least 1 week apart. A third PSA (PSA #3) is required to be greater than PSA&#xD;
             #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2.&#xD;
&#xD;
          -  Archive tumour tissue is available prior to recruitment for pharmacogenomic tests&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Prior therapy with agents targeting Insulin Growth Factor (IGF) and/or Insulin Growth&#xD;
             Factor Receptor (IGFR) pathway.&#xD;
&#xD;
          -  Patients that have been treated with any of the following within 4 weeks of starting&#xD;
             trial treatment: chemotherapy, immunotherapy, biological therapies, molecular&#xD;
             targeted, hormone therapy (except LHRH agonists and LHRH antagonists), radiotherapy&#xD;
             (except in case of localized radiotherapy for analgesic purpose or for lytic lesions&#xD;
             at risk of fracture which can then be completed within 2 weeks prior to study&#xD;
             treatment).&#xD;
&#xD;
          -  Use of any investigational drug within 4 weeks before start of trial treatment or&#xD;
             concomitantly with this trial.&#xD;
&#xD;
          -  Patients that have been treated with strong cytochrome P450, family 2, subfamily C,&#xD;
             polypeptide 8 (CYP2C8) inhibitors, CYP2C8 inducers, within 2 weeks of starting the&#xD;
             trial treatment.&#xD;
&#xD;
          -  Fridericia´s Corrected QT interval (QTcF) prolongation &gt; 450 ms or QT prolongation&#xD;
             deemed clinically relevant by the investigator (e.g., congenital long QT syndrome).&#xD;
             The QTcF will be calculated as the mean of the 3 ECGs taken at screening.&#xD;
&#xD;
          -  Patients with small cell or neuroendocrine tumours.&#xD;
&#xD;
          -  Patients with known or suspected leptomeningeal metastases.&#xD;
&#xD;
          -  Uncontrolled or poorly controlled hypertension.&#xD;
&#xD;
          -  Known human immunodeficiency virus infection or acquired immunodeficiency&#xD;
             syndrome-related illness.&#xD;
&#xD;
          -  Patients with epilepsy, seizures, or predisposing factors for seizure as judged by the&#xD;
             investigator.&#xD;
&#xD;
          -  Patients unable to comply with the protocol as judged by the investigator.&#xD;
&#xD;
          -  Active alcohol or active drug abuse as judged by the investigator.&#xD;
&#xD;
          -  A history of allergy to human monoclonal antibodies.&#xD;
&#xD;
          -  Patients who are sexually active and unwilling to use a medically acceptable method of&#xD;
             contraception, e.g. condom plus spermicide use for participating males, plus another&#xD;
             form of birth control such as implants, injectables, combined oral contraceptives,&#xD;
             intrauterine devices for female partners, during the trial and for at least three&#xD;
             months after end of active therapy. Men unwilling to agree to not donate sperm while&#xD;
             on trial drug and up to 6 months following the last dose of trial drug.&#xD;
&#xD;
          -  Previous or concomitant malignancies at any other site with the exception of the&#xD;
             following:&#xD;
&#xD;
               -  benign basal cell carcinoma&#xD;
&#xD;
               -  benign low grade transitional cell carcinoma of the bladder&#xD;
&#xD;
               -  other effectively treated malignancy that has been in remission for more than 5&#xD;
                  years and is considered to be cured&#xD;
&#xD;
          -  Only for patients entering phase Ib dose escalation and phase II cohorts:&#xD;
&#xD;
          -  Patients who have received more than 2 prior non-docetaxel containing cytotoxic&#xD;
             chemotherapy regimens for Metastatic Castration-Resistant Prostate Cancer (mCRPC).&#xD;
&#xD;
          -  Patients who have received a taxane based treatment or abiraterone, within 4 weeks&#xD;
             before start of study treatment.&#xD;
&#xD;
          -  Patients that have received prior enzalutamide in any setting will not be eligible.&#xD;
&#xD;
        Exclusion criterion only for patients entering phase Ib expansion cohort:&#xD;
&#xD;
        - Patients that have received prior taxane-based chemotherapy or abiraterone in any setting&#xD;
        will not be eligible for the expansion cohort.&#xD;
&#xD;
        Additional exclusion criterion for patients undergoing tumour biopsy:&#xD;
&#xD;
          -  For patients that are to undergo the tumour biopsy, a history of a hereditary bleeding&#xD;
             disorder, or clinically relevant major bleeding event in the past 6 months, as judged&#xD;
             by the investigator.&#xD;
&#xD;
          -  Further exclusion criteria apply&#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>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NewYork-Presbyterian/Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Sciences University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <zip>999077</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <zip>999077</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC - Daniel den Hoed</name>
      <address>
        <city>Rotterdam</city>
        <zip>3075 EA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tweesteden Ziekenhuis, locatie Tilburg</name>
      <address>
        <city>Tilburg</city>
        <zip>5042 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OncoCare Cancer Centre</name>
      <address>
        <city>Singapore</city>
        <zip>258499</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Duran i Reynals</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Valenciano de Oncología</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Clatterbridge Cancer Centre</name>
      <address>
        <city>Bebington, Wirral</city>
        <zip>CH63 4JY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velindre Cancer Centre</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 2TL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden Hospital, Sutton</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
  </removed_countries>
  <link>
    <url>https://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 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>
    <mesh_term>Prostatic Neoplasms, Castration-Resistant</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed &quot;Document Sharing Agreement&quot;. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.</ipd_access_criteria>
    <ipd_url>https://www.mystudywindow.com/msw/datasharing</ipd_url>
  </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/NCT02204072
org study id: 1280.8
secondary id: 2013-004011-41
nct id: NCT02204072
lead sponsor: 
The overall aim of the trial is to investigate the safety and anti-tumour activity of an
      experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide,
      compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients
      that have previously been treated and failed on docetaxel and abiraterone treatments.
      Initially, a tolerability and safety phase (phase Ib escalation) will be performed to confirm
      the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and enzalutamide
      that can be taken together.

      Once the MTD, or recommended phase II dose, have been determined an expansion cohort will
      also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have a
      rise in prostate serum antigen (PSA) levels. Patients may not have received prior docetaxel
      or abiraterone. Patients in this cohort will receive the MTD, or recommended phase II dose,
      of BI 836845 and enzalutamide determined in the phase Ib escalation phase.

      The randomised trial (phase II) will be an open label, parallel group study design in a 1:1
      ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the
      MTD/recommended doses, or enzalutamide alone (Arm B).

      In all parts of the trial safety, anti-tumour activity will be assessed, in addition to
      circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and
      determination of Overall Survival (OS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with dose limiting toxicities (phase Ib escalation)
time frame: 6 months
measure: Maximum tolerated dose (phase Ib escalation)
time frame: 6 months
measure: Prostate Surface Antigen (PSA) response - defined as a decline in PSA value >50% (which is confirmed by a second value 3 to 4 weeks apart) (phase Ib expansion)
time frame: Up to 3 years
measure: Radiological Progression free survival - time from randomisation to disease progression based on investigator assessment in bone, or soft tissue, or death (phase II)
time frame: Up to 3 years
measure: Overall survival - defined as the time from randomisation to death from any cause (phase II)
time frame: Up to 3 years
measure: Time to prostate serum antigen (PSA) progression - defined as the date that a 25% or greater increase in PSA, and an absolute increase of 2 ng/mL or more from the nadir, is documented, which is confirmed by a second value 3 or more weeks later (phase II)
time frame: Up to 3 years
measure: Maximum decline in PSA - compared to baseline that occurs at any point after treatment start (phase II)
time frame: Up to 3 years
measure: Percentage change in PSA - from baseline to week 12 of treatment (phase II)
time frame: Up to 3 years
measure: CTC response-CTC reduction compared to baseline for at least one time point after treatment start assessed by maximum change in CTC counts compared to baseline that occurs at any point after treatment start (phase II)
time frame: Up to 3 years
measure: Radiological progression free survival - defined as time from start of treatment to disease progression based on investigator assessment in bone based on PCWG2 or soft tissue based on modified RECIST 1.1 where applicable, or death (phase Ib expansion)
time frame: Up to 3 years
measure: Changes in CTC response - CTC reduction compared to baseline for at least one time point after treatment start assessed by CTC decline from, equal to, or more than, 5 to <5 cells per 7.5ml blood (phase II)
time frame: Up to 3 years
measure: Changes in circulating tumour cells (CTC) response - CTC reduction compared to baseline for at least one time point after treatment defined as CTC decline from, equal to, or more than, 5 to <5 cells per 7.5ml blood (phase Ib expansion)
time frame: Up to 3 years
measure: PSA response - defined as a decline in PSA value >50%, which is confirmed by a second value 3 to 4 weeks apart (phase II)
time frame: Up to 3 years
measure: Radiological progression free survival - defined as time from randomisation to disease progression based on central review in bone based on PCWG2 or soft tissue based on modified RECIST 1.1 where applicable, or death (phase II)
time frame: Up to 3 years
arm group label: BI 836845 & Enzalutamide
arm group type: Experimental
arm group label: Enzalutamide
arm group type: Active Comparator
intervention type: Drug
intervention name: BI 836845
arm group label: BI 836845 & Enzalutamide
intervention type: Drug
intervention name: Enzalutamide
arm group label: Enzalutamide
intervention type: Drug
intervention name: Enzalutamide
arm group label: BI 836845 & Enzalutamide
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: Hong Kong
country: Korea, Republic of
country: Netherlands
country: Singapore
country: Spain
country: Taiwan
country: United Kingdom
country: United States
country: Germany
url: https://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Prostatic Neoplasms, Castration-Resistant
sharing ipd: Yes
ipd description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
ipd access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
ipd url: https://www.mystudywindow.com/msw/datasharing