<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/NCT02209701</url>
  </required_header>
  <id_info>
    <org_study_id>1164.3</org_study_id>
    <nct_id>NCT02209701</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors</brief_title>
  <official_title>A Phase I Intensive Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors Who Receive Radiation Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin&#xD;
      and major metabolites in head and neck cancer and other cancer patients with solid tumors who&#xD;
      receive radiation therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>December 1999</start_date>
  <primary_completion_date type="Actual">July 2000</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>Assessment of serum concentrations of the analyte</measure>
    <time_frame>up to 6 hours after drug infusion</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of analyte excreted in urine</measure>
    <time_frame>0-3 and 3-6 hours after infustion</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>Porfiromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Porfiromycin</intervention_name>
    <arm_group_label>Porfiromycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically proven advanced head and neck cancer or other solid&#xD;
             tumors undergoing radiation therapy&#xD;
&#xD;
          -  Patients with prior chemotherapy will be considered if chemotherapy occurred more than&#xD;
             30 days prior to this study&#xD;
&#xD;
          -  Patients must be receiving concomitant radiotherapy (RT)&#xD;
&#xD;
          -  Performance status of ≥ 70% on the Karnofsky performance scale (KPS)&#xD;
&#xD;
          -  Must be ≥ 18 years of age&#xD;
&#xD;
          -  Expected survival of at least three months&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who meet any of the following clinical laboratory criteria:&#xD;
&#xD;
               -  Granulocyte count of &lt; 2000/mm**3&#xD;
&#xD;
               -  Platelets &lt; 75,000/mm**3&#xD;
&#xD;
               -  Serum creatinine &gt; 1.5 times the upper limit of normal&#xD;
&#xD;
               -  Bilirubin &gt; 1.5 times the upper limit of normal&#xD;
&#xD;
               -  Prothrombin time and partial thromboplastin time &gt; 1.5 times the upper limit of&#xD;
                  normal&#xD;
&#xD;
          -  Women who are pregnant&#xD;
&#xD;
          -  Men and women of child-bearing potential who are unwilling to utilize a medically&#xD;
             acceptable method of contraception&#xD;
&#xD;
          -  Patients who have any known bleeding disorder at the discretion of the investigator&#xD;
&#xD;
          -  Presence of any other life-threatening illness, such as unstable angina, severe oxygen&#xD;
             dependent chronic obstructive pulmonary disease, or unstable liver or renal disease&#xD;
&#xD;
          -  Treatment with granulocyte colony-stimulating factor, granulocyte-macrophage&#xD;
             colony-stimulating factor or Interleukin-1l within 30 days prior to the start of RT&#xD;
&#xD;
          -  Patients who have had prior exposure to mitomycin C or porfiromycin&#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 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 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>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Porfiromycin</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/NCT02209701
org study id: 1164.3
nct id: NCT02209701
lead sponsor: 
Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin
      and major metabolites in head and neck cancer and other cancer patients with solid tumors who
      receive radiation therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of serum concentrations of the analyte
time frame: up to 6 hours after drug infusion
measure: Amount of analyte excreted in urine
time frame: 0-3 and 3-6 hours after infustion
arm group label: Porfiromycin
arm group type: Experimental
intervention type: Drug
intervention name: Porfiromycin
arm group label: Porfiromycin
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: Head and Neck Neoplasms
mesh term: Porfiromycin