<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/NCT01662284</url>
  </required_header>
  <id_info>
    <org_study_id>CO12901</org_study_id>
    <secondary_id>2012-0230</secondary_id>
    <secondary_id>A534260</secondary_id>
    <secondary_id>SMPH\MEDICINE\HEM-ONC</secondary_id>
    <secondary_id>NCI-2012-01953</secondary_id>
    <nct_id>NCT01662284</nct_id>
  </id_info>
  <brief_title>Study of 124I-NM404 in Advanced Solid Malignancies</brief_title>
  <official_title>A Phase 1/2 Study of 124I-NM404 in Subjects With Advanced Solid Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cellectar Biosciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the use of investigational compound 124I-NM404 for&#xD;
      accurate detection and characterization of a wide variety of solid primary and metastatic&#xD;
      malignancies anywhere in the body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      124I-NM404 is a new investigational agent being developed to better identify local tumors and&#xD;
      cancerous tumors using imaging technologies such as positron emission tomography (PET) scans.&#xD;
      An investigational drug is a drug that has not been approved by the Food and Drug&#xD;
      Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by&#xD;
      the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed&#xD;
      tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more&#xD;
      accurately see and evaluate cancerous tumors. This agent has been safely studied in animals&#xD;
      and a limited number of human patients with lung cancer. This study is being done to&#xD;
      determine the best dose to use and to fully evaluate the images that result from using this&#xD;
      new agent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor determined this trial does not support their anticipated clinical development program.&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Optimal Imaging Parameters</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the optimal imaging parameters (dose, acquisition time, imaging time post injection, normal organ and tumor dosimetry) of 124I-NM404 in subjects with advanced solid malignancies with one of the following tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head &amp; neck cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>2 years</time_frame>
    <description>Number and grade of adverse events attributable to 124I-NM-404</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PET comparison</measure>
    <time_frame>2 years</time_frame>
    <description>compare 18F-FDG PET to 124I-NM404 PET</description>
  </secondary_outcome>
  <number_of_groups>9</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head &amp; Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Triple Negative Breast</arm_group_label>
    <description>124I-NM404 in triple negative breast cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prostate</arm_group_label>
    <description>124I-NM404 in prostate cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal</arm_group_label>
    <description>124I-NM404 in colorectal cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gastric</arm_group_label>
    <description>124I-NM404 in gastric cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ovarian</arm_group_label>
    <description>124I-NM404 in ovarian cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pancreatic</arm_group_label>
    <description>124I-NM404 in pancreatic cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Esophageal</arm_group_label>
    <description>124I-NM404 in esophageal cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sarcoma</arm_group_label>
    <description>124I-NM404 in soft tissue sarcoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Head &amp; Neck</arm_group_label>
    <description>124I-NM404 in head and neck cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>124I-NM404</intervention_name>
    <description>124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.</description>
    <arm_group_label>Colorectal</arm_group_label>
    <arm_group_label>Esophageal</arm_group_label>
    <arm_group_label>Gastric</arm_group_label>
    <arm_group_label>Head &amp; Neck</arm_group_label>
    <arm_group_label>Ovarian</arm_group_label>
    <arm_group_label>Pancreatic</arm_group_label>
    <arm_group_label>Prostate</arm_group_label>
    <arm_group_label>Sarcoma</arm_group_label>
    <arm_group_label>Triple Negative Breast</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be referred to the Phase I oncology research office by their treating&#xD;
        oncologist. Outside referrals will be managed by Cancer Connect who will ensure that&#xD;
        potential subjects are first evaluated by a UW medical oncologist in the cancer clinic who&#xD;
        will then refer them, if appropriate, to the Phase I oncology office.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of advanced solid malignancy.&#xD;
&#xD;
          -  Allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian,&#xD;
             pancreatic, esophageal, soft tissue sarcoma, and head &amp; neck cancer&#xD;
&#xD;
          -  Disease must be at least 1cm in diameter&#xD;
&#xD;
          -  Brain metastasis must be stable for at least one month.&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Anticipated survival less than 5 years, as per the treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Skin lesions only&#xD;
&#xD;
          -  Chemotherapy or radiotherapy within 1 week&#xD;
&#xD;
          -  Residual toxicities of grade 2 or greater from prior therapy&#xD;
&#xD;
          -  Adequate organ function as per specified laboratory parameter&#xD;
&#xD;
          -  Platelet count &gt; or = to 75,000/uL&#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>Glenn Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cancer.wisc.edu/</url>
    <description>University of Wisconsin Carbone Cancer Center</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>November 19, 2019</last_update_submitted>
  <last_update_submitted_qc>November 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2019</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>Sarcoma</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/NCT01662284
org study id: CO12901
secondary id: 2012-0230
secondary id: A534260
secondary id: SMPH\MEDICINE\HEM-ONC
secondary id: NCI-2012-01953
nct id: NCT01662284
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to assess the use of investigational compound 124I-NM404 for
      accurate detection and characterization of a wide variety of solid primary and metastatic
      malignancies anywhere in the body.
124I-NM404 is a new investigational agent being developed to better identify local tumors and
      cancerous tumors using imaging technologies such as positron emission tomography (PET) scans.
      An investigational drug is a drug that has not been approved by the Food and Drug
      Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by
      the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed
      tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more
      accurately see and evaluate cancerous tumors. This agent has been safely studied in animals
      and a limited number of human patients with lung cancer. This study is being done to
      determine the best dose to use and to fully evaluate the images that result from using this
      new agent.
observational model: Case-Only
time perspective: Prospective
measure: Optimal Imaging Parameters
time frame: 2 years
description: To determine the optimal imaging parameters (dose, acquisition time, imaging time post injection, normal organ and tumor dosimetry) of 124I-NM404 in subjects with advanced solid malignancies with one of the following tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer
measure: Adverse events
time frame: 2 years
description: Number and grade of adverse events attributable to 124I-NM-404
measure: PET comparison
time frame: 2 years
description: compare 18F-FDG PET to 124I-NM404 PET
arm group label: Triple Negative Breast
description: 124I-NM404 in triple negative breast cancer
arm group label: Prostate
description: 124I-NM404 in prostate cancer
arm group label: Colorectal
description: 124I-NM404 in colorectal cancer
arm group label: Gastric
description: 124I-NM404 in gastric cancer
arm group label: Ovarian
description: 124I-NM404 in ovarian cancer
arm group label: Pancreatic
description: 124I-NM404 in pancreatic cancer
arm group label: Esophageal
description: 124I-NM404 in esophageal cancer
arm group label: Sarcoma
description: 124I-NM404 in soft tissue sarcoma
arm group label: Head & Neck
description: 124I-NM404 in head and neck cancer
intervention type: Drug
intervention name: 124I-NM404
description: 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
arm group label: Colorectal
arm group label: Esophageal
arm group label: Gastric
arm group label: Head & Neck
arm group label: Ovarian
arm group label: Pancreatic
arm group label: Prostate
arm group label: Sarcoma
arm group label: Triple Negative Breast
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Glenn Liu, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: https://cancer.wisc.edu/
description: University of Wisconsin Carbone Cancer Center
responsible party type: Sponsor
mesh term: Sarcoma