<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/NCT02254005</url>
  </required_header>
  <id_info>
    <org_study_id>1191.1</org_study_id>
    <nct_id>NCT02254005</nct_id>
  </id_info>
  <brief_title>Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer</brief_title>
  <official_title>An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Female Patients With CD44v6 Positive Metastatic Breast Cancer With Repeated Administration in Patients With Clinical Benefit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2002</start_date>
  <primary_completion_date type="Actual">December 2004</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>Maximum tolerated dose (MTD) of bivatuzumab mertansine</measure>
    <time_frame>up to day 21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>up to day 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant findings in laboratory tests</measure>
    <time_frame>up to day 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant findings in vital signs</measure>
    <time_frame>up to day 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor response rate</measure>
    <time_frame>up to 1 year</time_frame>
    <description>assessed by response evaluation criteria in solid tumours (RECIST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of bivatuzumab mertansine</measure>
    <time_frame>up to day 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)</measure>
    <time_frame>up to day 21</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with development of human anti-human antibodies (HAHA)</measure>
    <time_frame>up to day 21</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>single dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bivatuzumab mertansine</intervention_name>
    <arm_group_label>single dose escalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. female patients aged 18 years or older&#xD;
&#xD;
          2. patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells&#xD;
&#xD;
          3. patients with metastases pretreated with anthracyclines and taxanes (unless&#xD;
             contraindications to taxanes and / or anthracyclines) or not amenable to established&#xD;
             treatments&#xD;
&#xD;
          4. measurable tumour deposits by one or more radiological techniques (MRI, CT)&#xD;
&#xD;
          5. life expectancy of at least 6 months&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2&#xD;
&#xD;
          7. patients must have given written informed consent (which must be consistent with&#xD;
             International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local&#xD;
             legislation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients&#xD;
             of the trial drugs&#xD;
&#xD;
          2. known secondary malignancy requiring therapy&#xD;
&#xD;
          3. active infectious disease&#xD;
&#xD;
          4. brain metastases requiring therapy&#xD;
&#xD;
          5. neuropathy common toxicity criteria (CTC) grade 2 or above&#xD;
&#xD;
          6. absolute neutrophil count less than 1,500/mm3&#xD;
&#xD;
          7. platelet count less than 100,000/mm3&#xD;
&#xD;
          8. bilirubin greater than 1.5 mg/dl (&gt; 26 μmol/L, système internationale (SI) unit&#xD;
             equivalent)&#xD;
&#xD;
          9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than&#xD;
             3 times the upper limit of normal&#xD;
&#xD;
         10. serum creatinine greater than 1.5 mg/dl (&gt; 132 μmol/L, SI unit equivalent)&#xD;
&#xD;
         11. concomitant non-oncological diseases which are considered relevant for the evaluation&#xD;
             of the safety of the trial drug&#xD;
&#xD;
         12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial&#xD;
             drug or during the trial (except for present trial drug)&#xD;
&#xD;
         13. radiotherapy to breast and thorax region within the past four weeks before inclusion&#xD;
             or during the trial&#xD;
&#xD;
         14. women who are sexually active and unwilling to use a medically acceptable method of&#xD;
             contraception&#xD;
&#xD;
         15. pregnancy or lactation&#xD;
&#xD;
         16. treatment with other investigational drugs or participation in another clinical trial&#xD;
             within the past four weeks before start of therapy or concomitantly with this trial&#xD;
             (except for present trial drug)&#xD;
&#xD;
         17. patients unable to comply with the protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>September 2014</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 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>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maytansine</mesh_term>
    <mesh_term>Bivatuzumab mertansine</mesh_term>
  </intervention_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/NCT02254005
org study id: 1191.1
nct id: NCT02254005
lead sponsor: 
Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose (MTD) of bivatuzumab mertansine
time frame: up to day 21
measure: Incidence of adverse events
time frame: up to day 21
measure: Number of patients with clinically significant findings in laboratory tests
time frame: up to day 21
measure: Number of patients with clinically significant findings in vital signs
time frame: up to day 21
measure: Tumor response rate
time frame: up to 1 year
description: assessed by response evaluation criteria in solid tumours (RECIST)
measure: Concentration of bivatuzumab mertansine
time frame: up to day 21
measure: Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)
time frame: up to day 21
measure: Number of patients with development of human anti-human antibodies (HAHA)
time frame: up to day 21
arm group label: single dose escalation
arm group type: Experimental
intervention type: Drug
intervention name: bivatuzumab mertansine
arm group label: single dose escalation
criteria: 
gender: Female
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: Breast Neoplasms
mesh term: Maytansine
mesh term: Bivatuzumab mertansine