<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/NCT01696565</url>
  </required_header>
  <id_info>
    <org_study_id>PH-CP002-2</org_study_id>
    <nct_id>NCT01696565</nct_id>
  </id_info>
  <brief_title>PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy</brief_title>
  <official_title>PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PhytoHealth Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PhytoHealth Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this Phase I/II study are:&#xD;
&#xD;
        1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy&#xD;
           receiving chemotherapy and to define a &quot;Study Dose&quot; for Phase II.&#xD;
&#xD;
        2. To evaluate the hematopoietic and immunological responses after administering of PG2.&#xD;
           Primarily to study the biological response of PG2, defined as WBC count in this study,&#xD;
           and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is the first step for PG2 clinical development in Taiwan in order to further&#xD;
      establish its safety and efficacy profile and to build the basis for larger trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2001</start_date>
  <completion_date type="Actual">October 2003</completion_date>
  <primary_completion_date type="Actual">October 2003</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase I: To find the maximum tolerated dose (MTD) or the highest tolerated dose (HTD) as the study dose of PG2; Phase II: To use the study dose and assess the WBC level of PG2</measure>
    <time_frame>within 14 days of each chemotherapy cycle</time_frame>
    <description>For phase I study, the primary endpoint is to determine a safe dosage of PG2 by the dose escalation design.&#xD;
For phase II study, the primary endpoint is to compare the WBC level between PG2 plus chemotherapy and chemotherapy alone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels</measure>
    <time_frame>within 14 days of each chemotherapy cycle</time_frame>
    <description>For phase II study, the secondary endpoint is to compare the levels of IL-2, IL-6, TGF-beta and G-CSF between PG2 plus chemotherapy and chemotherapy alone.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Neoplasm Metastasis</condition>
  <condition>Neoplasm Recurrence</condition>
  <arm_group>
    <arm_group_label>125 mg/day Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>125 mg/day PG2 treatment continuously for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>250 mg/day Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 mg/day PG2 treatment continuously for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>500 mg/day Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>500 mg/day PG2 treatment continuously for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PG2</intervention_name>
    <description>Injectable</description>
    <arm_group_label>125 mg/day Treatment Arm</arm_group_label>
    <arm_group_label>250 mg/day Treatment Arm</arm_group_label>
    <arm_group_label>500 mg/day Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must have malignancy with metastatic or recurrent diseases.&#xD;
&#xD;
          -  Patient must have a minimum of thirteen days period elapsed from any previous&#xD;
             chemotherapy or radiotherapy and all treatment-related toxicities subsided.&#xD;
&#xD;
          -  Patient must have at least 2 courses of chemotherapy treatment left, and a minimum of&#xD;
             13 days between the administration of the last dose of the chemotherapy with PG2 and&#xD;
             the start of the next course of chemotherapy.&#xD;
&#xD;
          -  Performance status is 0-2 by ECOG scale.&#xD;
&#xD;
          -  Patient's compliance and geographic proximity that allow adequate follow up.&#xD;
&#xD;
          -  Adequate bone marrow function before the chemotherapy&#xD;
&#xD;
          -  Adequate liver and renal function before the chemotherapy&#xD;
&#xD;
          -  Written informed consent from patients&#xD;
&#xD;
          -  Woman with childbearing potential should use contraception method through the whole&#xD;
             PG2 treatment course.&#xD;
&#xD;
          -  After the previous course of chemotherapy, the nadir of WBC dropped between 1000 to&#xD;
             3000/ mm3 (for phase II only).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PG2 skin test is positive.&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Breast feeding&#xD;
&#xD;
          -  Prior radiotherapy more than 30% of the bone marrow involved.&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Bone marrow transplantation or brain disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Woei-Yao Kao, Chief</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Tzu Chi Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>March 28, 2011</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>myelosuppression</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>Astragalus membranaceus</keyword>
  <keyword>hematopoietic response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Recurrence</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/NCT01696565
org study id: PH-CP002-2
nct id: NCT01696565
lead sponsor: 
has dmc: No
The objectives of this Phase I/II study are:

        1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy
           receiving chemotherapy and to define a "Study Dose" for Phase II.

        2. To evaluate the hematopoietic and immunological responses after administering of PG2.
           Primarily to study the biological response of PG2, defined as WBC count in this study,
           and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.
This study is the first step for PG2 clinical development in Taiwan in order to further
      establish its safety and efficacy profile and to build the basis for larger trials.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase I: To find the maximum tolerated dose (MTD) or the highest tolerated dose (HTD) as the study dose of PG2; Phase II: To use the study dose and assess the WBC level of PG2
time frame: within 14 days of each chemotherapy cycle
description: For phase I study, the primary endpoint is to determine a safe dosage of PG2 by the dose escalation design.
For phase II study, the primary endpoint is to compare the WBC level between PG2 plus chemotherapy and chemotherapy alone.
measure: Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels
time frame: within 14 days of each chemotherapy cycle
description: For phase II study, the secondary endpoint is to compare the levels of IL-2, IL-6, TGF-beta and G-CSF between PG2 plus chemotherapy and chemotherapy alone.
arm group label: 125 mg/day Treatment Arm
arm group type: Experimental
description: 125 mg/day PG2 treatment continuously for 7 days
arm group label: 250 mg/day Treatment Arm
arm group type: Experimental
description: 250 mg/day PG2 treatment continuously for 7 days
arm group label: 500 mg/day Treatment Arm
arm group type: Experimental
description: 500 mg/day PG2 treatment continuously for 7 days
intervention type: Drug
intervention name: PG2
description: Injectable
arm group label: 125 mg/day Treatment Arm
arm group label: 250 mg/day Treatment Arm
arm group label: 500 mg/day Treatment Arm
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Woei-Yao Kao, Chief
role: Principal Investigator
affiliation: Taichung Tzu Chi Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Recurrence