<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/NCT02211859</url>
  </required_header>
  <id_info>
    <org_study_id>1216.2</org_study_id>
    <nct_id>NCT02211859</nct_id>
  </id_info>
  <brief_title>Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit</brief_title>
  <official_title>An Open Phase I Repeated Dose Escalation Study of BI 2536 BS Administered Intravenously in Patients With Advanced Solid Tumours 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>
      Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile&#xD;
      of BI 2536. Assessment of safety and efficacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2004</start_date>
  <primary_completion_date type="Actual">December 2007</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 maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT)</measure>
    <time_frame>up to 3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with drug-related adverse events</measure>
    <time_frame>up to 24 days after last drug administration</time_frame>
    <description>according to common terminology criteria for adverse events (CTCAE) 3.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal laboratory findings</measure>
    <time_frame>up to 24 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Eastern Cooperative Oncology Group (ECOG) performance score</measure>
    <time_frame>baseline, up to 24 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>up to 24 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with objective tumor response</measure>
    <time_frame>up to 24 days after last drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax (maximum concentration of the analyte in plasma)</measure>
    <time_frame>up to 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax (time from dosing to maximum concentration)</measure>
    <time_frame>up to 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_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 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)</measure>
    <time_frame>up to 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz (terminal rate constant in plasma)</measure>
    <time_frame>up to 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2 (terminal half-life of the analyte in plasma)</measure>
    <time_frame>up to 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRT (mean residence time of the analyte in the body after intravenous administration)</measure>
    <time_frame>up to 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL (total clearance of the analyte in the plasma after intravascular administration)</measure>
    <time_frame>up to 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)</measure>
    <time_frame>up to 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vss (apparent volume of distribution at steady state following intravascular administration)</measure>
    <time_frame>up to 264 hours after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>BI 2536</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single escalating dose, followed by repeated administration in patients with clinical benefit</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 2536</intervention_name>
    <arm_group_label>BI 2536</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients with confirmed diagnosis of advanced, non resectable and/or metastatic solid&#xD;
             tumours, who have failed conventional treatment, or for whom no therapy of proven&#xD;
             efficacy exists, or who are not amenable to established forms of treatment&#xD;
&#xD;
          -  Evaluable tumour deposits&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Life expectancy of at least six months&#xD;
&#xD;
          -  Written informed consent consistent with international conference of harmonization&#xD;
             (ICH) - good clinical practice (GCP) and local legislation&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2&#xD;
&#xD;
          -  Full recovery from all therapy-related toxicities from previous chemo-, hormone-,&#xD;
             immuno-, or radiotherapies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Serious illness or concomitant non-oncological disease considered by the investigator&#xD;
             to be incompatible with the protocol&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Active infectious disease&#xD;
&#xD;
          -  Known brain metastases&#xD;
&#xD;
          -  Second malignancy requiring therapy&#xD;
&#xD;
          -  Absolute neutrophil count less than 1500/mm3&#xD;
&#xD;
          -  Platelet count less than 100 000/mm3&#xD;
&#xD;
          -  Bilirubin greater than 1.5 mg/dl (&gt; 26 μmol/L)&#xD;
&#xD;
          -  Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than&#xD;
             2.5 times the upper limit of normal (if related to liver metastases greater than five&#xD;
             times the upper limit of normal)&#xD;
&#xD;
          -  Serum creatinine greater than 1.5 mg/dl (&gt; 132 μmol/L)&#xD;
&#xD;
          -  Women and men who are sexually active and unwilling to use a medically acceptable&#xD;
             method of contraception&#xD;
&#xD;
          -  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;
      </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 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02211859
org study id: 1216.2
nct id: NCT02211859
lead sponsor: 
Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile
      of BI 2536. Assessment of safety and efficacy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determination of the maximum tolerated dose (MTD) by occurrence of dose limiting toxicities (DLT)
time frame: up to 3 weeks
measure: Number of patients with drug-related adverse events
time frame: up to 24 days after last drug administration
description: according to common terminology criteria for adverse events (CTCAE) 3.0
measure: Number of patients with abnormal laboratory findings
time frame: up to 24 days after last drug administration
measure: Change in Eastern Cooperative Oncology Group (ECOG) performance score
time frame: baseline, up to 24 days after last drug administration
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 24 days after last drug administration
measure: Number of patients with objective tumor response
time frame: up to 24 days after last drug administration
measure: Cmax (maximum concentration of the analyte in plasma)
time frame: up to 264 hours after drug administration
measure: tmax (time from dosing to maximum concentration)
time frame: up to 264 hours after drug administration
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 264 hours after drug administration
measure: %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)
time frame: up to 264 hours after drug administration
measure: λz (terminal rate constant in plasma)
time frame: up to 264 hours after drug administration
measure: t1/2 (terminal half-life of the analyte in plasma)
time frame: up to 264 hours after drug administration
measure: MRT (mean residence time of the analyte in the body after intravenous administration)
time frame: up to 264 hours after drug administration
measure: CL (total clearance of the analyte in the plasma after intravascular administration)
time frame: up to 264 hours after drug administration
measure: Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose)
time frame: up to 264 hours after drug administration
measure: Vss (apparent volume of distribution at steady state following intravascular administration)
time frame: up to 264 hours after drug administration
arm group label: BI 2536
arm group type: Experimental
description: single escalating dose, followed by repeated administration in patients with clinical benefit
intervention type: Drug
intervention name: BI 2536
arm group label: BI 2536
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