<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/NCT02215044</url>
  </required_header>
  <id_info>
    <org_study_id>1216.8</org_study_id>
    <nct_id>NCT02215044</nct_id>
  </id_info>
  <brief_title>Dose-finding Study of BI 2536 Administered in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer</brief_title>
  <official_title>A Phase I Open-label Dose-finding Study of Intravenous BI 2536 Administered in Repeated 4-week Cycles as Repeated Doses on Day 1 and Day 15 in Combination With Gemcitabine Administered on Day 1, Day 8 and Day 15 in Patients With Locally Advanced or Metastatic Pancreatic 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>
      Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was&#xD;
      given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15&#xD;
      every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and&#xD;
      characterisation the antitumor activity, pharmacokinetic (PK) profile, and CA 19-9 tumor&#xD;
      marker response in response to the combination of BI 2536 with gemcitabine in patients with&#xD;
      locally advanced or metastatic pancreatic adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>June 2007</start_date>
  <primary_completion_date type="Actual">December 2008</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>Occurence of dose limiting toxicity according to CTCAE</measure>
    <time_frame>up to day 28 of each cycle</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)</measure>
    <time_frame>Pre-dose, up to 192 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum measured concentration of the analytes in plasma (Cmax)</measure>
    <time_frame>Pre-dose, up to 192 hours after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective tumour responses based on Response evaluation criteria in solid tumors (RECIST) criteria</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival status</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor marker (CA19-9) response to treatment with BI 2536 and gemcitabine</measure>
    <time_frame>Day 1 of each treatment cycle prior to administration of study treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>BI 2536 in combination with gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 2536, intravenous</intervention_name>
    <arm_group_label>BI 2536 in combination with gemcitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine, intravenous</intervention_name>
    <arm_group_label>BI 2536 in combination with gemcitabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with histologically or cytologically confirmed locally advanced, unresectable&#xD;
             or metastasized adenocarcinoma of the pancreas who:&#xD;
&#xD;
               1. have not received gemcitabine chemotherapy for locally advanced or metastatic&#xD;
                  pancreatic cancer or&#xD;
&#xD;
               2. have progressive disease not before at least 6 months from cessation of adjuvant&#xD;
                  gemcitabine chemotherapy following curative surgical tumor resection&#xD;
&#xD;
          -  Male or female patient aged 18 years or older&#xD;
&#xD;
          -  Life expectancy of at least three (3) months&#xD;
&#xD;
          -  Eastern Co-operative Oncology Group (ECOG) performance score of 2 or less&#xD;
&#xD;
          -  Patient must have given written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior chemo- (other than adjuvant gemcitabine), hormone- (other than Megace®) or&#xD;
             immunotherapy&#xD;
&#xD;
          -  Ampullary carcinoma of the pancreas&#xD;
&#xD;
          -  Brain metastases, which are symptomatic or require therapy&#xD;
&#xD;
          -  Patients who have any other life-threatening illness or organ system dysfunction,&#xD;
             which in the opinion of the investigator, would either compromise patient safety or&#xD;
             interfere with the evaluation of the safety of the test drug&#xD;
&#xD;
          -  Other malignancies diagnosed within the past five (5) years (other than&#xD;
             non-melanomatous skin cancer)&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &lt;1,500/μl, platelet count &lt;150,000/μl, or hemoglobin&#xD;
             &lt;9 g/dl&#xD;
&#xD;
          -  Total bilirubin &gt;1.8mg/dl (&gt;30.78 μmol/l,, international system of units (SI)&#xD;
             equivalent) under adequate drainage measures (in case of obstructive jaundice)&#xD;
&#xD;
          -  No hepatic metastases: Aspartate amino transferase (AST) and/or alanine amino&#xD;
             transferase (ALT) &gt;2.5 x upper limit of normal (ULN). Hepatic metastases: aspartate&#xD;
             amino transferase (AST) and/or alanine amino transferase (ALT) &gt;5 x ULN&#xD;
&#xD;
          -  Serum creatinine &gt;2.0 mg/dl (&gt;176 μmol/L, SI Unit equivalent)&#xD;
&#xD;
          -  Radiotherapy within the last 2 weeks prior to or during treatment with the trial drug&#xD;
&#xD;
          -  Patients with any serious active infection (i.e., requiring an IV antibiotic,&#xD;
             antifungal, or antiviral agents)&#xD;
&#xD;
          -  Patients with known HIV, Hepatitis-B or -C infection&#xD;
&#xD;
          -  Known or suspected active drug or alcohol abuse&#xD;
&#xD;
          -  Women of child-bearing potential; men who are able to father a child and are unwilling&#xD;
             to use a medically acceptable method of contraception during the trial&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Treatment with any investigational drug within the past 4 weeks or within less than&#xD;
             four half-life times of the investigational drug before treatment with the trial drug&#xD;
             and/or persistence of toxicities of prior anticancer therapies which are deemed to be&#xD;
             clinically relevant&#xD;
&#xD;
          -  Patient unable to comply with the protocol&#xD;
&#xD;
          -  Patients requiring warfarin (Coumadin®) or patients with a known pre-existing&#xD;
             coagulopathy unrelated to pancreatic cancer (This means, for example, that patient&#xD;
             with a long (years) history or recurrent venocclusive disease clearly preceding the&#xD;
             diagnosis of pancreatic cancer will be excluded from the study. Patients with recent&#xD;
             hypercoagulable state (ie deep vein thrombosis or pulmonary embolism) due to&#xD;
             pancreatic cancer who are clinically stable on low molecular weight heparin will not&#xD;
             be excluded)&#xD;
&#xD;
          -  Patients with neuropathy (sensory or motor) ≥ common terminology criteria for adverse&#xD;
             events (CTCAE) 3&#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 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 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>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</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/NCT02215044
org study id: 1216.8
nct id: NCT02215044
lead sponsor: 
Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was
      given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15
      every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and
      characterisation the antitumor activity, pharmacokinetic (PK) profile, and CA 19-9 tumor
      marker response in response to the combination of BI 2536 with gemcitabine in patients with
      locally advanced or metastatic pancreatic adenocarcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurence of dose limiting toxicity according to CTCAE
time frame: up to day 28 of each cycle
measure: Area under the concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
time frame: Pre-dose, up to 192 hours after start of treatment
measure: Maximum measured concentration of the analytes in plasma (Cmax)
time frame: Pre-dose, up to 192 hours after start of treatment
measure: Objective tumour responses based on Response evaluation criteria in solid tumors (RECIST) criteria
time frame: up to 1 year
measure: Survival status
time frame: up to 1 year
measure: Tumor marker (CA19-9) response to treatment with BI 2536 and gemcitabine
time frame: Day 1 of each treatment cycle prior to administration of study treatment
arm group label: BI 2536 in combination with gemcitabine
arm group type: Experimental
intervention type: Drug
intervention name: BI 2536, intravenous
arm group label: BI 2536 in combination with gemcitabine
intervention type: Drug
intervention name: Gemcitabine, intravenous
arm group label: BI 2536 in combination with gemcitabine
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: Pancreatic Neoplasms
mesh term: Gemcitabine