<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/NCT02199886</url>
  </required_header>
  <id_info>
    <org_study_id>1152.3</org_study_id>
    <nct_id>NCT02199886</nct_id>
  </id_info>
  <brief_title>Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection</brief_title>
  <official_title>A Phase I Single Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics&#xD;
      associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in&#xD;
      tumour to that of normal tissue in patients with non-small cell lung cancer and to measure&#xD;
      human anti-human antibody (HAHA) concentrations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>July 1998</start_date>
  <primary_completion_date type="Actual">December 2001</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</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>Occurrence of dose-limiting toxicities as defined by Common toxicity criteria (CTC)</measure>
    <time_frame>up to 30 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with abnormal biodistribution for 131I BIBH 1</measure>
    <time_frame>up to day 30</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor absorbed dose of 131I BIBH 1</measure>
    <time_frame>week 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of human anti-human antibodies (HAHA)</measure>
    <time_frame>up to day 30</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Lung Neoplasms</condition>
  <arm_group>
    <arm_group_label>BIBH 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dose escalation: 0.5, 2, 10 or 20mg/m**2, 7 days prior to surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBH 1</intervention_name>
    <description>labeled with eight to ten millicurie of 131I</description>
    <arm_group_label>BIBH 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed primary or secondary advanced non-small cell lung cancer&#xD;
&#xD;
          -  Eligible for a lung biopsy or scheduled for surgery that would provide biopsy material&#xD;
&#xD;
          -  Karnofsky performance status of ≥ 70&#xD;
&#xD;
          -  Expected survival of ≥ 3 months&#xD;
&#xD;
          -  Greater than or equal to 18 years of age&#xD;
&#xD;
          -  Absolute granulocyte count ≥ 2.5 x 10**9/L&#xD;
&#xD;
          -  Lymphocyte count &gt; 0.7 x 10**9/L&#xD;
&#xD;
          -  Platelet count ≥ 100 x 10**9/L&#xD;
&#xD;
          -  Serum Creatinine ≤ 2.0 mg/dl (0.20 mmol/L)&#xD;
&#xD;
          -  Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 3x upper limit of&#xD;
             normal&#xD;
&#xD;
          -  Total bilirubin &lt; 2 mg/dl or 34µmol (SI unit equivalent)&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active metastatic disease to the central nervous system, exhibited by new or enlarging&#xD;
             lesions on CT or MRI scan or within 3 months of treatment (i.e., surgery or&#xD;
             radiotherapy) for brain metastases&#xD;
&#xD;
          -  Exposure to an investigational agent within four weeks of the BIBH 1 infusion&#xD;
&#xD;
          -  Patients that are not fully recovered from surgery. Because of the potential binding&#xD;
             of BIBH 1 to healing scars, patients with incomplete healing at an incision site, as&#xD;
             evidenced by incomplete granulation, infection or localized edema are excluded&#xD;
&#xD;
          -  Chemotherapy or immunotherapy within four weeks preceding entry (six weeks for&#xD;
             nitrsoureas and/or mitomycin-C.)&#xD;
&#xD;
          -  Previous administration of a murine, chimeric or humanised measurement and/or antibody&#xD;
             fragment&#xD;
&#xD;
          -  Serious illness: e.g., active infections requiring antibiotics, bleeding disorders or&#xD;
             diseases considered by the investigator to have potential for interfering with&#xD;
             obtaining accurate results from this study&#xD;
&#xD;
          -  Women who are breast-feeding or pregnant&#xD;
&#xD;
          -  Men and women of childbearing potential who are unwilling to utilize a medically&#xD;
             acceptable method of contraception&#xD;
&#xD;
          -  Previous participation in this study&#xD;
&#xD;
          -  Patients who have autoimmune disease or hypertopic skin conditions that possibly&#xD;
             over-express Fibroblast Activation Protein and may be targeted by the antibody. These&#xD;
             diseases include active inflammatory arthritis, cirrhosis and keloids.&#xD;
&#xD;
          -  Patients with unstable angina pectoris. Patients prescribed medication to control&#xD;
             their angina pectoris must be on a fixed dose for at least 1 month prior to screening&#xD;
             to be eligible for the trial.&#xD;
&#xD;
          -  Patients who experienced a myocardial infarction within 3 months of Screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 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>Lung Neoplasms</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/NCT02199886
org study id: 1152.3
nct id: NCT02199886
lead sponsor: 
Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics
      associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in
      tumour to that of normal tissue in patients with non-small cell lung cancer and to measure
      human anti-human antibody (HAHA) concentrations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of dose-limiting toxicities as defined by Common toxicity criteria (CTC)
time frame: up to 30 days
measure: Number of patients with abnormal biodistribution for 131I BIBH 1
time frame: up to day 30
measure: Tumor absorbed dose of 131I BIBH 1
time frame: week 2
measure: Concentration of human anti-human antibodies (HAHA)
time frame: up to day 30
arm group label: BIBH 1
arm group type: Experimental
description: dose escalation: 0.5, 2, 10 or 20mg/m**2, 7 days prior to surgery
intervention type: Drug
intervention name: BIBH 1
description: labeled with eight to ten millicurie of 131I
arm group label: BIBH 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Lung Neoplasms