<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/NCT03757754</url>
  </required_header>
  <id_info>
    <org_study_id>HISUN-HPPH-I-2014</org_study_id>
    <nct_id>NCT03757754</nct_id>
  </id_info>
  <brief_title>HPPH Photodynamic Therapy for Patients With Esophageal Cancer</brief_title>
  <acronym>HPPH</acronym>
  <official_title>Evalution of Safety, Tolerability and Pharmacokinetics of of HPPH in Ascending Dose for Cancer Patients in Phase I Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Hisun Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Hisun Pharmaceutical Co. Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase I study was to investigate the safety and tolerability of the photosensitizer (PS)&#xD;
      2-[1-hexyloxyethyl]-2-devinyl pyropheophorbide-a (HPPH) for injection in patients with&#xD;
      Esophageal Cancer. It was to characterize the pharmacokinetics of HPPH and efficacy of HPPH.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study is phase I study to evaluate the safety, tolerability, and pharmacokinetics&#xD;
      of multiple ascending injection doses of HPPH in Patients with Esophageal Cancer. Up to 30&#xD;
      patients are planned to be enrolled in 6 cohorts with each cohort consisting of 3-6 patients&#xD;
      ( male and/or female patients). In each cohort, patients will receive HPPH and Lyophilized&#xD;
      treatment. The dose escalation in Cohorts was from 2.5 to 3, 3.5, 4, 5, and 6mg/m2 of HPPH,&#xD;
      respectively, administered intravenous drop infusion over 1 hour, once daily, and a fixed&#xD;
      light dose of 150 J/cm delivered 48 hours after infusion of HPPH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 3, 2015</start_date>
  <completion_date type="Anticipated">May 27, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 20, 2019</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Multiple Ascending Dose, Multiple groups, Multiple centers</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>open</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The number of dose-limiting toxicity</measure>
    <time_frame>Day 1 to Day 10</time_frame>
    <description>Dose-limiting toxicity would be assesed by CTCAE4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed concentration (Cmax)</measure>
    <time_frame>Day 1 to Day 84</time_frame>
    <description>PK measurement expressed as Cmax for HPPH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum concentration (tmax)</measure>
    <time_frame>Day 1 to Day 84</time_frame>
    <description>PK measurement expressed as Tmax for HPPH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent terminal elimination phase half (t1/2)</measure>
    <time_frame>Day 1 to Day 84</time_frame>
    <description>PK measurement expressed as t1/2 for HPPH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve over the dosing interval (AUC0-t)</measure>
    <time_frame>Day 1 to Day 84</time_frame>
    <description>PK measurement expressed as AUC0-t for HPPH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞)</measure>
    <time_frame>Day 1 to Day 84</time_frame>
    <description>PK measurement expressed as AUC0-∞ for HPPH</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Esophageal Cancer</condition>
  <arm_group>
    <arm_group_label>HPPH 2.5 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPPH 2.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPPH 3 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPPH 3 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPPH 3.5 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPPH 3.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPPH 4 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPPH 4 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPPH 5 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPPH 5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPPH 6 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HPPH 6 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HPPH 2.5 mg/m2</intervention_name>
    <description>HPPH was administered as a single, 2.5 mg/m2, slow intravenous infusion over 1 hour , and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
    <arm_group_label>HPPH 2.5 mg/m2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HPPH 3 mg/m2</intervention_name>
    <description>HPPH was administered as a single, 3 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
    <arm_group_label>HPPH 3 mg/m2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HPPH 3.5 mg/m2</intervention_name>
    <description>HPPH was administered as a single, 3.5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
    <arm_group_label>HPPH 3.5 mg/m2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HPPH 4 mg/m2</intervention_name>
    <description>HPPH was administered as a single, 4 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
    <arm_group_label>HPPH 4 mg/m2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HPPH 5 mg/m2</intervention_name>
    <description>HPPH was administered as a single, 5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
    <arm_group_label>HPPH 5 mg/m2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HPPH 6 mg/m2</intervention_name>
    <description>HPPH was administered as a single, 6 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.</description>
    <arm_group_label>HPPH 6 mg/m2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older, Male and female subjects with practicing a highly effective&#xD;
             form of birth control, and a signed consent;&#xD;
&#xD;
          -  Subjects who was diagnosed as Esophageal Cancer or carcinoma of gastric cardia by&#xD;
             endoscopy and Biopsy pathology at T1-T3 stage.&#xD;
&#xD;
          -  Subjects who could not be taken surgery or chemotherapy; with unsucessful surgery or&#xD;
             failed chemotherapy; who had refused surgery and chemotherapy&#xD;
&#xD;
          -  ECOG 0-2, Life expectancy would be more than 3-month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects were diagnosed as Tracheoesophageal fistula or Esophageal mediatinal fistula,&#xD;
             or more than 60 years old with having three kinds of Heart, Lung, Liver and Kidney&#xD;
             commorbities;&#xD;
&#xD;
          -  Hematopoietic WBC &lt; 3×109/L; HGB &lt;80g/L; PLT &lt;80×109/L; PLT &lt;1.5 times upper limit of&#xD;
             normal (ULN)&#xD;
&#xD;
          -  Hepatic TBIL&gt;1.5ULN, ALT or AST &gt;2.5 ULN&#xD;
&#xD;
          -  Alkaline phosphatase &gt; 3 times ULN&#xD;
&#xD;
          -  Uncontrol Hypertension: Bp&gt;160/100mmHg&#xD;
&#xD;
          -  Uncomtrol Diabetes&#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>Huilong Liu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>General Hospital of Beijing Miitary Command of PLA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oncology, General Hospital of Beijing Miitary Command of PLA</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PHHP</keyword>
  <keyword>Esophageal cancer</keyword>
  <keyword>Phase I study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</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/NCT03757754
org study id: HISUN-HPPH-I-2014
nct id: NCT03757754
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Phase I study was to investigate the safety and tolerability of the photosensitizer (PS)
      2-[1-hexyloxyethyl]-2-devinyl pyropheophorbide-a (HPPH) for injection in patients with
      Esophageal Cancer. It was to characterize the pharmacokinetics of HPPH and efficacy of HPPH.
The present study is phase I study to evaluate the safety, tolerability, and pharmacokinetics
      of multiple ascending injection doses of HPPH in Patients with Esophageal Cancer. Up to 30
      patients are planned to be enrolled in 6 cohorts with each cohort consisting of 3-6 patients
      ( male and/or female patients). In each cohort, patients will receive HPPH and Lyophilized
      treatment. The dose escalation in Cohorts was from 2.5 to 3, 3.5, 4, 5, and 6mg/m2 of HPPH,
      respectively, administered intravenous drop infusion over 1 hour, once daily, and a fixed
      light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Multiple Ascending Dose, Multiple groups, Multiple centers
primary purpose: Treatment
masking: None (Open Label)
masking description: open
measure: The number of dose-limiting toxicity
time frame: Day 1 to Day 10
description: Dose-limiting toxicity would be assesed by CTCAE4.0
measure: Maximum observed concentration (Cmax)
time frame: Day 1 to Day 84
description: PK measurement expressed as Cmax for HPPH
measure: Time to maximum concentration (tmax)
time frame: Day 1 to Day 84
description: PK measurement expressed as Tmax for HPPH
measure: Apparent terminal elimination phase half (t1/2)
time frame: Day 1 to Day 84
description: PK measurement expressed as t1/2 for HPPH
measure: Area under the concentration-time curve over the dosing interval (AUC0-t)
time frame: Day 1 to Day 84
description: PK measurement expressed as AUC0-t for HPPH
measure: Area under the concentration-time curve from zero extrapolated to infinity (AUC0-∞)
time frame: Day 1 to Day 84
description: PK measurement expressed as AUC0-∞ for HPPH
arm group label: HPPH 2.5 mg/m2
arm group type: Experimental
description: HPPH 2.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 3 mg/m2
arm group type: Experimental
description: HPPH 3 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 3.5 mg/m2
arm group type: Experimental
description: HPPH 3.5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 4 mg/m2
arm group type: Experimental
description: HPPH 4 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 5 mg/m2
arm group type: Experimental
description: HPPH 5 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 6 mg/m2
arm group type: Experimental
description: HPPH 6 mg/m2, Freeze-dried powder injection, intravenous infusion once daily, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
intervention type: Drug
intervention name: HPPH 2.5 mg/m2
description: HPPH was administered as a single, 2.5 mg/m2, slow intravenous infusion over 1 hour , and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 2.5 mg/m2
intervention type: Drug
intervention name: HPPH 3 mg/m2
description: HPPH was administered as a single, 3 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 3 mg/m2
intervention type: Drug
intervention name: HPPH 3.5 mg/m2
description: HPPH was administered as a single, 3.5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 3.5 mg/m2
intervention type: Drug
intervention name: HPPH 4 mg/m2
description: HPPH was administered as a single, 4 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 4 mg/m2
intervention type: Drug
intervention name: HPPH 5 mg/m2
description: HPPH was administered as a single, 5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 5 mg/m2
intervention type: Drug
intervention name: HPPH 6 mg/m2
description: HPPH was administered as a single, 6 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
arm group label: HPPH 6 mg/m2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Huilong Liu, PhD
role: Principal Investigator
affiliation: General Hospital of Beijing Miitary Command of PLA
facility: 
country: China
responsible party type: Sponsor
mesh term: Esophageal Neoplasms