<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/NCT01727869</url>
  </required_header>
  <id_info>
    <org_study_id>R1400-ST-1113</org_study_id>
    <nct_id>NCT01727869</nct_id>
  </id_info>
  <brief_title>Study of REGN1400 Alone and in Combination With Erlotinib or Cetuximab in Patients With Certain Types of Cancer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regeneron Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in&#xD;
      combination with erlotinib or cetuximab administered to patients with certain types of&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab</measure>
    <time_frame>Day 1 - Day 28</time_frame>
    <description>Safety will be assessed through analysis of laboratory data, physical examination findings and vital signs according to the schedule of assessments, in addition to the spontaneous reporting of adverse events according to CTCAE version 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recommended Phase 2 Dose (RP2D)</measure>
    <time_frame>Day 1 to Day 28</time_frame>
    <description>Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>REGN1400</intervention_name>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erlotinib</intervention_name>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria include, but are not limited to, the following:&#xD;
&#xD;
          1. Confirmed diagnosis of certain unresectable or metastatic cancers&#xD;
&#xD;
          2. Adequate Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
&#xD;
          3. Adequate hepatic, renal and bone marrow function&#xD;
&#xD;
          4. Resolution of toxicity from prior therapy to grade less than/ = to 1&#xD;
&#xD;
        Exclusion Criteria include, but are not limited to, the following:&#xD;
&#xD;
          1. Active brain metastases&#xD;
&#xD;
          2. Thromboembolic events &lt; 6 months prior to study&#xD;
&#xD;
          3. Patients with a recent history (within 5 years) of another malignancy.&#xD;
&#xD;
          4. Investigational or any antitumor treatment with a maximum of 4 half-lives or&#xD;
             administered 30 days prior to the initial administration of REGN1400&#xD;
&#xD;
          5. Patients who are pregnant or nursing&#xD;
&#xD;
          6. Prior treatment with ErbB3 inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>April 2, 2015</last_update_submitted>
  <last_update_submitted_qc>April 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cetuximab</mesh_term>
    <mesh_term>Erlotinib Hydrochloride</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/NCT01727869
org study id: R1400-ST-1113
nct id: NCT01727869
lead sponsor: 
has dmc: No
This is an open-label, multicenter, ascending multiple dose study of REGN1400 alone and in
      combination with erlotinib or cetuximab administered to patients with certain types of
      cancer.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary objective of the study is to characterize the safety profile of REGN1400 alone and in combination with erlotinib or cetuximab
time frame: Day 1 - Day 28
description: Safety will be assessed through analysis of laboratory data, physical examination findings and vital signs according to the schedule of assessments, in addition to the spontaneous reporting of adverse events according to CTCAE version 4.
measure: Recommended Phase 2 Dose (RP2D)
time frame: Day 1 to Day 28
description: Determine a recommended phase 2 dose (RP2D) of REGN1400 in combination with erlotinib or cetuximab
arm group label: Cohort 1
arm group type: Experimental
description: Dosing regimen 1: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
arm group label: Cohort 2
arm group type: Experimental
description: Dosing regimen 2: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
arm group label: Cohort 3
arm group type: Experimental
description: Dosing regimen 3: REGN1400 or REGN1400 and erlotinib or REGN1400 and cetuximab
intervention type: Drug
intervention name: REGN1400
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
intervention type: Drug
intervention name: Erlotinib
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
intervention type: Drug
intervention name: Cetuximab
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cetuximab
mesh term: Erlotinib Hydrochloride