<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/NCT01733004</url>
  </required_header>
  <id_info>
    <org_study_id>MM-141-01-01-01</org_study_id>
    <nct_id>NCT01733004</nct_id>
  </id_info>
  <brief_title>A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors</brief_title>
  <official_title>A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merrimack Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merrimack Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a &quot;3+3&quot;&#xD;
      design, evaluating MM-141 at varying dose levels and frequencies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Actual">January 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity and number of adverse events related to escalating doses of MM-141</measure>
    <time_frame>2 years</time_frame>
    <description>Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MM-141 monotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MM-141 and Everolimus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MM-141 and Abraxane and Gemcitabine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MM-141</intervention_name>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced malignant solid tumors for which no curative therapy exists that has recurred&#xD;
             or pgrogressed following standard therapy&#xD;
&#xD;
          -  Eighteen years of age or above&#xD;
&#xD;
          -  Able to understand and sign an informed consent (or have a legal representative who is&#xD;
             able to do so)&#xD;
&#xD;
          -  Measurable disease according to RECIST v1.1&#xD;
&#xD;
          -  ECOG Performance Score of 0 or 1&#xD;
&#xD;
          -  Adequate bone marrow, hepatic, renal and cardiac function&#xD;
&#xD;
          -  Willing to abstain from sexual intercourse or to use an effective form of&#xD;
             contraception during the study and for 90 days following the last dose of MM-141&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection or fever &gt; 38.5°C during screening visits or on the first scheduled&#xD;
             day of dosing&#xD;
&#xD;
          -  Symptomatic CNS disease&#xD;
&#xD;
          -  Received other recent antitumor therapy&#xD;
&#xD;
          -  Pregnant or breast feeding&#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>Chrystal Louis, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Merrimack Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</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>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>August 3, 2016</last_update_submitted>
  <last_update_submitted_qc>August 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Hepatocellular Carcinoma</keyword>
  <keyword>Oncology</keyword>
  <keyword>Phase I</keyword>
  <keyword>ErbB3</keyword>
  <keyword>IGF-1R</keyword>
  <keyword>Everolimus</keyword>
  <keyword>Gemcitabine</keyword>
  <keyword>Abraxane</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_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/NCT01733004
org study id: MM-141-01-01-01
nct id: NCT01733004
lead sponsor: 
has dmc: No
This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a "3+3"
      design, evaluating MM-141 at varying dose levels and frequencies.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Severity and number of adverse events related to escalating doses of MM-141
time frame: 2 years
description: Determine the Phase II dose based either on the maximum tolerated dose (MTD) or recommended dose in patients with advanced solid malignancies.
arm group label: Arm A
arm group type: Experimental
description: MM-141 monotherapy
arm group label: Arm B
arm group type: Experimental
description: MM-141 and Everolimus
arm group label: Arm C
arm group type: Experimental
description: MM-141 and Abraxane and Gemcitabine
intervention type: Drug
intervention name: MM-141
arm group label: Arm A
arm group label: Arm B
arm group label: Arm C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chrystal Louis, MD, MPH
role: Study Director
affiliation: Merrimack Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
country: France
country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Hepatocellular