<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/NCT02198274</url>
  </required_header>
  <id_info>
    <org_study_id>1152.10</org_study_id>
    <nct_id>NCT02198274</nct_id>
  </id_info>
  <brief_title>Intravenous BIBH 1 in Patients With Metastatic Colorectal Cancer</brief_title>
  <official_title>A Phase II Uncontrolled Sudy to Evaluate the Antitumour Activity and Safety of Intravenous BIBH 1, Administered in a Weekly Dose of 100 mg in 12 Weeks, in Patients With Metastatic Colorectal 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 evaluate the anti-tumour activity, safety and pharmacokinetics of unlabelled&#xD;
      sibrotuzumab administered weekly (seven days +/- one day) at a dose of 100 mg (a total of 12&#xD;
      administrations) in patients with metastatic colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2000</start_date>
  <primary_completion_date type="Actual">October 2000</primary_completion_date>
  <phase>Phase 2</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>Anti-tumour response</measure>
    <time_frame>4 weeks after the last administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to tumour progression</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to loss of response</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease progression-free survival time</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in titers of human anti-human antibody (HAHA)</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and intensity of adverse events graded by Common toxicity criteria (CTC)</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the maximum toxicity grade observed for each patient</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of on-study deaths</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum drug concentration (Cmax)</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum drug concentration (Cmin)</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve (AUC)</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total serum clearance (CL)</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution at steady state (Vss)</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half-life (t1/2)</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>BIBH 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIBH 1</intervention_name>
    <description>100 mg/week</description>
    <arm_group_label>BIBH 1</arm_group_label>
    <other_name>Sibrotuzumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with metastatic colorectal cancer International Union Against Cancer (UICC)&#xD;
             Stage IV who are progressive under at least two previous chemotherapy regimes or who&#xD;
             refused conventional treatment or who are not eligible for conventional treatment&#xD;
&#xD;
          -  Progressive disease documented by subsequent computed tomography (CT) or magnetic&#xD;
             resonance imaging (MRI) scanning prior to study entry. The last CT or MRI scans must&#xD;
             be performed within 1 month before study entry. The first CT or MRI scan should be&#xD;
             conducted within 6 months before study entry&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2&#xD;
&#xD;
          -  Expected survival of ≥ 6 months&#xD;
&#xD;
          -  Greater than or equal to 18 years of age&#xD;
&#xD;
          -  Platelet count ≥ 100 x 10**9/L&#xD;
&#xD;
          -  Total leukocytes ≥ 2500/mm**3&#xD;
&#xD;
          -  Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 4 x upper limit of&#xD;
             normal&#xD;
&#xD;
          -  Total bilirubin ≤ 2.0 mg/dl (or 34µmol/L, Systeme International (SI) unit equivalent)&#xD;
&#xD;
          -  Serum creatinine ≤ 2.0 mg/dl (0.20 mmol/l)&#xD;
&#xD;
          -  Written informed consent in accordance with Good Clinical Practice and local&#xD;
             legislation&#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 investigation agent within 30 days prior to the first BIBH 1 infusion&#xD;
&#xD;
          -  Patients who are not fully recovered from surgery (incomplete healing)&#xD;
&#xD;
          -  Chemotherapy or immunotherapy within 30 days prior to the first BIBH 1 infusion&#xD;
&#xD;
          -  Radiation therapy to the symptomatic sites included for tumour measurements within 30&#xD;
             days prior to study entry&#xD;
&#xD;
          -  Previous administration of a murine, chimeric or humanised measurement and/or antibody&#xD;
             fragment (e.g. BIBH 1, Panorex)&#xD;
&#xD;
          -  Serious illness: e.g., active infections requiring antibiotics, bleeding disorders,&#xD;
             patients with known untreated or unstable coronary heart disease (e.g. unstable angina&#xD;
             or myocardial infarction within 6 months prior to study entry) or diseases considered&#xD;
             by the investigator to have potential for interfering with obtaining accurate results&#xD;
             from this study&#xD;
&#xD;
          -  Women who are breast-feeding or pregnant&#xD;
&#xD;
          -  Men and women of childbearing potential who are unwilling to utilise a medically&#xD;
             acceptable method of contraception&#xD;
&#xD;
          -  Patients who suffer from autoimmune diseases&#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 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 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>Colorectal 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/NCT02198274
org study id: 1152.10
nct id: NCT02198274
lead sponsor: 
Study to evaluate the anti-tumour activity, safety and pharmacokinetics of unlabelled
      sibrotuzumab administered weekly (seven days +/- one day) at a dose of 100 mg (a total of 12
      administrations) in patients with metastatic colorectal cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anti-tumour response
time frame: 4 weeks after the last administration
measure: Time to tumour progression
time frame: up to 16 weeks
measure: Time to loss of response
time frame: up to 16 weeks
measure: Disease progression-free survival time
time frame: up to 16 weeks
measure: Changes in titers of human anti-human antibody (HAHA)
time frame: up to 16 weeks
measure: Incidence and intensity of adverse events graded by Common toxicity criteria (CTC)
time frame: up to 16 weeks
measure: Assessment of the maximum toxicity grade observed for each patient
time frame: up to 16 weeks
measure: Frequency of on-study deaths
time frame: up to 16 weeks
measure: Maximum drug concentration (Cmax)
time frame: up to 16 weeks
measure: Minimum drug concentration (Cmin)
time frame: up to 16 weeks
measure: Area under the concentration-time curve (AUC)
time frame: up to 16 weeks
measure: Total serum clearance (CL)
time frame: up to 16 weeks
measure: Volume of distribution at steady state (Vss)
time frame: up to 16 weeks
measure: Terminal half-life (t1/2)
time frame: up to 16 weeks
measure: Mean residence time (MRT)
time frame: up to 16 weeks
arm group label: BIBH 1
arm group type: Experimental
intervention type: Drug
intervention name: BIBH 1
description: 100 mg/week
arm group label: BIBH 1
other name: 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: Colorectal Neoplasms