<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/NCT02209727</url>
  </required_header>
  <id_info>
    <org_study_id>1152.6</org_study_id>
    <nct_id>NCT02209727</nct_id>
  </id_info>
  <brief_title>Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer</brief_title>
  <official_title>A Phase I Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic 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>
      Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose&#xD;
      administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>December 2000</start_date>
  <primary_completion_date type="Actual">June 2002</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>Determination of the dose limiting toxicity (DLT)</measure>
    <time_frame>up to 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of the maximum tolerated dose (MTD)</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>MTD is defined as the highest dose below which two patients experience DLT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of toxicity</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>graded according to the Common Toxicity Criteria (CTC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria</measure>
    <time_frame>8 weeks after therapeutic infusion</time_frame>
  </secondary_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>131I-Sibrotuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single therapy dose administered over 60 minutes at week 4</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>131I-Sibrotuzumab</intervention_name>
    <description>50 mg Sibrotuzumab conjugated with 131I</description>
    <arm_group_label>131I-Sibrotuzumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Evidence of advanced, non-resectable, and/or metastatic non-small cell lung cancer and&#xD;
             at least one previous conventional treatment for advanced disease&#xD;
&#xD;
          -  Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Measurable or evaluable disease, determined by World Health Organization (WHO)&#xD;
             criteria using standard imaging modalities, including ultrasound, X-ray, CT and/or&#xD;
             Magnetic Resonance Imaging (MRI). Bone scans and/or antibody scans are not to be used&#xD;
             to determine the extent of the disease&#xD;
&#xD;
          -  Expected survival of ≥ 16 weeks&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Platelet count ≥ 100 x 10**9/L&#xD;
&#xD;
          -  Absolute neutrophil count ≥ 2.0 x 10**9/L&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal or &lt; 5 x upper limit of&#xD;
             normal if liver metastases are present&#xD;
&#xD;
          -  Total bilirubin ≤ 2mg/dL&#xD;
&#xD;
          -  Serum creatinine ≤ 2mg/dL&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known brain metastases&#xD;
&#xD;
          -  Exposure to an investigational agent within 30 days prior to receiving the scout dose&#xD;
&#xD;
          -  Incomplete recovery from surgery or incomplete healing of an incision site or evidence&#xD;
             of infection&#xD;
&#xD;
          -  Treatment with cytotoxic chemotherapy, radiation or immunosuppressive therapy within&#xD;
             the 30 days (42 days for nitrosoureas and/or mitomycin C) of the scout infusion.&#xD;
             Patients using inhaled corticosteroids are considered eligible for enrollment&#xD;
&#xD;
          -  Serious illnesses, i.e., active infections requiring antibiotics, bleeding disorders&#xD;
             or other serious illnesses precluding the use of either 131I or sibrotuzumab&#xD;
&#xD;
          -  Women who are breast-feeding or pregnant&#xD;
&#xD;
          -  Men and women who were sexually active and are unwilling to utilize a medically&#xD;
             acceptable method of contraception&#xD;
&#xD;
          -  Hypertrophic skin disease or autoimmune disease that possibly involves over-expression&#xD;
             of fibroblast activation protein (FAP), which can be targeted by the antibody. These&#xD;
             diseases include active inflammatory arthritis, cirrhosis, and keloids&#xD;
&#xD;
          -  Unstable angina pectoris. Patients prescribed medication to control their angina&#xD;
             pectoris must have been on a fixed dose for at least 1 month prior to screening to be&#xD;
             eligible for trial enrollment&#xD;
&#xD;
          -  Myocardial infarction within 3 months prior to screening&#xD;
&#xD;
          -  New York Heart Association (NYHA) Heart failure stage III or IV, or a left ventricular&#xD;
             ejection fraction of ≤ 40 %&#xD;
&#xD;
          -  Impaired lung function, measured by a decrease in forced expiratory volume at one&#xD;
             second (FEV1) to less than 50 % of the predicted normal value&#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>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 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/NCT02209727
org study id: 1152.6
nct id: NCT02209727
lead sponsor: 
Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose
      administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determination of the dose limiting toxicity (DLT)
time frame: up to 12 weeks
measure: Determination of the maximum tolerated dose (MTD)
time frame: up to 12 weeks
description: MTD is defined as the highest dose below which two patients experience DLT
measure: Occurrence of toxicity
time frame: up to 12 weeks
description: graded according to the Common Toxicity Criteria (CTC)
measure: Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria
time frame: 8 weeks after therapeutic infusion
arm group label: 131I-Sibrotuzumab
arm group type: Experimental
description: single therapy dose administered over 60 minutes at week 4
intervention type: Drug
intervention name: 131I-Sibrotuzumab
description: 50 mg Sibrotuzumab conjugated with 131I
arm group label: 131I-Sibrotuzumab
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: Carcinoma, Non-Small-Cell Lung