<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/NCT02204059</url>
  </required_header>
  <id_info>
    <org_study_id>1170.3</org_study_id>
    <nct_id>NCT02204059</nct_id>
  </id_info>
  <brief_title>Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Non-small Cell Lung Cancer</brief_title>
  <official_title>A Phase I Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Non-small Cell Lung Cancer</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 primary objectives of this study is to assess the safety and tolerability of&#xD;
      intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to&#xD;
      investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in&#xD;
      patients with non-small cell lung cancer (NSCLC)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 1999</start_date>
  <primary_completion_date type="Actual">February 2001</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</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 patients with adverse events</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of Human-Anti-Human-Antibody (HAHA)</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Biodistribution of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples</measure>
    <time_frame>up to 96 hours post infusion</time_frame>
    <description>assessed by radioimmunoscintigraphy expressed as no, low, medium or high</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples</measure>
    <time_frame>after surgery on day 8</time_frame>
    <description>Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax (Maximum measured concentration of the analyte in plasma)</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>tmax (Time from dosing to the maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>t½ (Terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MRT (Mean residence time of the analyte in the body)</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vss (Apparent volume of distribution under steady state conditions)</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vz (Apparent volume of distribution during the terminal phase)</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL (Total body clearance)</measure>
    <time_frame>up to 6 weeks post infusion</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>hMAb BIWA 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bivatuzumab: 186 Re-labelled humanised monoclonal antibody BIWA 4</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hMAb BIWA 4</intervention_name>
    <arm_group_label>hMAb BIWA 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histological or cytological confirmation of Non small cell lung&#xD;
             cancer (NSCLC) stage I, II or IIIa according to the staging system of the American&#xD;
             Joint Committee on Cancer (AJCC)&#xD;
&#xD;
          -  Patients destined for resection of the tumour&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
          -  Patients younger than 80 years of age&#xD;
&#xD;
          -  Patients who had given 'written informed consent'&#xD;
&#xD;
          -  Patients with a life expectancy of at least 3 months&#xD;
&#xD;
          -  Patients with a good performance status: Karnofsky &gt; 60&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life-threatening infection, allergic diathesis, organ failure (bilirubin &gt; 30µmol/l&#xD;
             and/or creatinine &gt; 150 µmol/l) or evidence of a recent myocardial infarction on&#xD;
             Electrocardiogram (ECG) or unstable angina pectoris&#xD;
&#xD;
          -  Pre-menopausal women (last menstruation &lt;= 1 year prior to study start)&#xD;
&#xD;
               -  Not surgically sterile (hysterectomy, tubal ligation) and&#xD;
&#xD;
               -  Not practicing acceptable means of birth control, (or not planned to be continued&#xD;
                  throughout the study). Acceptable methods of birth control include oral,&#xD;
                  implantable or injectable contraceptives&#xD;
&#xD;
          -  Women with a positive serum pregnancy test at baseline&#xD;
&#xD;
          -  White blood cell count &lt; 3000/mm³, granulocyte count &lt; 1500/mm³ or platelet count &lt;&#xD;
             100000/mm³. Details of prior chemotherapy and radiotherapy had to be known.&#xD;
&#xD;
          -  Hematological disorders, congestive heart failure, bronchial asthma, alimentary or&#xD;
             contact allergy, severe atopy or allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</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>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</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>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <!-- 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/NCT02204059
org study id: 1170.3
nct id: NCT02204059
lead sponsor: 
The primary objectives of this study is to assess the safety and tolerability of
      intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to
      investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in
      patients with non-small cell lung cancer (NSCLC)
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with adverse events
time frame: up to 6 weeks post infusion
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 6 weeks post infusion
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 6 weeks post infusion
measure: Presence of Human-Anti-Human-Antibody (HAHA)
time frame: up to 6 weeks post infusion
measure: Biodistribution of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
time frame: up to 96 hours post infusion
description: assessed by radioimmunoscintigraphy expressed as no, low, medium or high
measure: Uptake of 186Re-labelled hMAb BIWA 4 in tumour and normal tissue samples
time frame: after surgery on day 8
description: Biodistribution assessed from biopsy sample as percentage of the injected dose per kg tissue (%ID/kg)
measure: AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
time frame: up to 6 weeks post infusion
measure: Cmax (Maximum measured concentration of the analyte in plasma)
time frame: up to 6 weeks post infusion
measure: tmax (Time from dosing to the maximum concentration of the analyte in plasma)
time frame: up to 6 weeks post infusion
measure: t½ (Terminal half-life of the analyte in plasma)
time frame: up to 6 weeks post infusion
measure: MRT (Mean residence time of the analyte in the body)
time frame: up to 6 weeks post infusion
measure: Vss (Apparent volume of distribution under steady state conditions)
time frame: up to 6 weeks post infusion
measure: Vz (Apparent volume of distribution during the terminal phase)
time frame: up to 6 weeks post infusion
measure: CL (Total body clearance)
time frame: up to 6 weeks post infusion
arm group label: hMAb BIWA 4
arm group type: Experimental
description: Bivatuzumab: 186 Re-labelled humanised monoclonal antibody BIWA 4
intervention type: Drug
intervention name: hMAb BIWA 4
arm group label: hMAb BIWA 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung