<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/NCT02211833</url>
  </required_header>
  <id_info>
    <org_study_id>1216.5</org_study_id>
    <nct_id>NCT02211833</nct_id>
  </id_info>
  <brief_title>Dose Escalation Study of BI 2536 With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer</brief_title>
  <official_title>A Phase I Open-label Dose Escalation Study of Intravenous BI 2536 Together With Pemetrexed in Previously Treated Patients With 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>
      Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose&#xD;
      (MTD), and efficacy of BI 2536 administered in combination with pemetrexed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2006</start_date>
  <primary_completion_date type="Actual">February 2009</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 BI 2536 in combination with pemetrexed</measure>
    <time_frame>up to 3 weeks</time_frame>
    <description>by occurrence of dose limiting toxicities (DLT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events during combination therapy</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>according to common terminology criteria for adverse events (CTCAE) 3.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective tumor response after combination therapy</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>according to Response Evaluation Criteria in Solid Tumours (RECIST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of objective tumor response after combination therapy</measure>
    <time_frame>up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal laboratory findings</measure>
    <time_frame>up to 20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Eastern Cooperative Oncology Group (ECOG) performance score</measure>
    <time_frame>baseline, up to 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>BI 2536 with pemetrexed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>combination therapy phase may be followed by BI 2536 monotherapy for eligible patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 2536</intervention_name>
    <arm_group_label>BI 2536 with pemetrexed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <arm_group_label>BI 2536 with pemetrexed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathologic or cytologic confirmed diagnosis of NSCLC&#xD;
&#xD;
          2. Recurrent, advanced or metastatic NSCLC that had progressed following 1 prior&#xD;
             chemotherapy regimen for advanced disease. Patients could have received prior adjuvant&#xD;
             chemotherapy as long as the disease free interval was longer than 1 year.&#xD;
&#xD;
          3. Measurable disease by 1 or more techniques (CT, MRI) according to RECIST criteria&#xD;
&#xD;
          4. Male or female aged 18 years or older&#xD;
&#xD;
          5. Life expectancy of at least 3 months&#xD;
&#xD;
          6. Eastern Cooperative Oncology Group (ECOG) performance score 0-2&#xD;
&#xD;
          7. Written informed consent that was consistent with International Conference on&#xD;
             Harmonization (ICH) - Good Clinical Practice (GCP) guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment with an investigational drug in another clinical study within the 28 days&#xD;
             prior to the start of therapy or concomitantly with this study&#xD;
&#xD;
          2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the&#xD;
             28 days prior to Day 1 of treatment period 1 of this trial&#xD;
&#xD;
          3. Any persisting toxicities that were deemed to be clinically significant from the&#xD;
             previous therapy&#xD;
&#xD;
          4. Received more than 1 prior chemotherapy regimen for advanced disease (not including&#xD;
             prior adjuvant therapy). Patients could have received prior epidermal growth factor&#xD;
             receptor tyrosine kinase inhibitors&#xD;
&#xD;
          5. Unwilling or unable to take folic acid and vitamin B12 supplementation&#xD;
&#xD;
          6. Active brain metastases (stable for &lt;28 days, symptomatic, or requiring concurrent&#xD;
             steroids). Patients who had received prior whole brain irradiation and whose brain&#xD;
             metastases were stable according to the criteria above were not excluded&#xD;
&#xD;
          7. Other active malignancy diagnosed within the past 3 years (other than non-melanomatous&#xD;
             skin cancer and cervical intraepithelial neoplasia)&#xD;
&#xD;
          8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness or social situation that would have limited&#xD;
             compliance with trial requirement or which were considered relevant for the evaluation&#xD;
             of the efficacy or safety of the trial drug&#xD;
&#xD;
          9. Unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to&#xD;
             the day of and up to 2 days after the administration of pemetrexed&#xD;
&#xD;
         10. Received prior therapy with pemetrexed&#xD;
&#xD;
         11. Absolute neutrophil count (ANC) ≤1 500/μL, platelet count ≤100 000/μL, or haemoglobin&#xD;
             &lt;9 mg/dL&#xD;
&#xD;
         12. Total bilirubin &gt;1.5 mg/dL (26 μmol/L), alanine aminotransferase (ALT) and/or&#xD;
             aspartate aminotransferase (AST) ≥2.5 x the upper limit of normal (ULN), except in&#xD;
             cases of known liver metastasis where a maximum 5 x ULN was acceptable&#xD;
&#xD;
         13. Serum creatinine level &gt;1.5 mg/dL and or creatinine clearance &lt;45 mL/min&#xD;
&#xD;
         14. Sexually active and unwilling to use a medically acceptable method of contraception&#xD;
&#xD;
         15. Pregnancy or breast feeding&#xD;
&#xD;
         16. Known or suspected active alcohol or drug abuse&#xD;
&#xD;
         17. Unable to comply with the protocol&#xD;
&#xD;
         18. Any known hypersensitivity to the trial drugs or their excipients&#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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pemetrexed</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/NCT02211833
org study id: 1216.5
nct id: NCT02211833
lead sponsor: 
Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose
      (MTD), and efficacy of BI 2536 administered in combination with pemetrexed
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose (MTD) of BI 2536 in combination with pemetrexed
time frame: up to 3 weeks
description: by occurrence of dose limiting toxicities (DLT)
measure: Number of patients with adverse events during combination therapy
time frame: up to 20 weeks
description: according to common terminology criteria for adverse events (CTCAE) 3.0
measure: Objective tumor response after combination therapy
time frame: up to 20 weeks
description: according to Response Evaluation Criteria in Solid Tumours (RECIST)
measure: Duration of objective tumor response after combination therapy
time frame: up to 1 year
measure: Progression free survival (PFS)
time frame: up to 2 years
measure: Overall survival
time frame: up to 2 years
measure: Number of patients with abnormal laboratory findings
time frame: up to 20 weeks
measure: Change in Eastern Cooperative Oncology Group (ECOG) performance score
time frame: baseline, up to 1 year
arm group label: BI 2536 with pemetrexed
arm group type: Experimental
description: combination therapy phase may be followed by BI 2536 monotherapy for eligible patients
intervention type: Drug
intervention name: BI 2536
arm group label: BI 2536 with pemetrexed
intervention type: Drug
intervention name: Pemetrexed
arm group label: BI 2536 with pemetrexed
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
mesh term: Pemetrexed