<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/NCT04482257</url>
  </required_header>
  <id_info>
    <org_study_id>HE072-BE-002</org_study_id>
    <nct_id>NCT04482257</nct_id>
  </id_info>
  <brief_title>Bioequivalence Study of Irinotecan Liposome Injection in Chinese Advanced Pancreatic Cancer.</brief_title>
  <official_title>*Official Title: Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC Ouyi Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSPC Ouyi 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>
      Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial&#xD;
      of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study was to determine the bioequivalence of two formulations of&#xD;
      Irinotecan Liposome Injection (70mg/m2) in Chinese patients with Advanced Pancreatic Cancer,&#xD;
      under fasting condition. These data were to be evaluated statistically to determine if the&#xD;
      products meet bioequivalence criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>0 -190 hours</time_frame>
    <description>Cmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-t</measure>
    <time_frame>0 -190 hours</time_frame>
    <description>The exposure of Total Irinotecan and Free Irinotecan from time (0) to the last quantifiable concentration (t) will be measured for the test product (CSPC) or the reference product (Ipsen).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞</measure>
    <time_frame>0 -190 hours</time_frame>
    <description>The exposure of Total Irinotecan and Free Irinotecan from time (0) to infinity (∞) will be calculated for the test product (CSPC) or the reference product (Ipsen).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>0 -190 hours</time_frame>
    <description>The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>t1/2</measure>
    <time_frame>0 -190 hours</time_frame>
    <description>The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>λz</measure>
    <time_frame>0 -190 hours</time_frame>
    <description>The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Advanced Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>T-R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R-T</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan Liposome Injection combined with 5-FU/LV</intervention_name>
    <description>Drug: Irinotecan Liposome Injection 70mg/m2 (CSPC) combined with 5-FU/LV; Drug: Irinotecan Liposome Injection 70mg/m2 (Ipsen, ONIVYDETM) combined with 5-FU/LV;</description>
    <arm_group_label>R-T</arm_group_label>
    <arm_group_label>T-R</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed written informed consent for participation in the trial.&#xD;
&#xD;
          2. Advanced pancreatic cancer diagnosed by histopathology and / or cytology.&#xD;
&#xD;
          3. Age ≥ 18 years, men or women. BMI is above 17.&#xD;
&#xD;
          4. ECOG score 0 to 2.&#xD;
&#xD;
          5. Life expectancy ≥ 3 months.&#xD;
&#xD;
          6. Adequate bone marrow function.&#xD;
&#xD;
          7. Adequate hepatic function.&#xD;
&#xD;
          8. Adequate renal function.&#xD;
&#xD;
          9. Patient with reproductive potential must agree to use adequate contraception from the&#xD;
             signing of informed consent to at least 6 months after the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have a severe allergy or a significant history of hypersensitivity or an&#xD;
             idiopathic reaction attributed to irinotecan or compounds of similar chemical&#xD;
             composition to irinotecan ;&#xD;
&#xD;
          2. Patients who have previously used irinotecan liposomes and experienced treatment&#xD;
             failure or serious adverse reactions;&#xD;
&#xD;
          3. Patients with severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine,&#xD;
             immune system, skin, musculoskeletal, neurological or psychiatric diseases that&#xD;
             occurred within 3 months of the first dose of the study drug, and not suitable for&#xD;
             this study as determined by the researchers;&#xD;
&#xD;
          4. Patients who have undergone major surgery within 4 weeks of screening or have a&#xD;
             schedule for major surgery during the study period;&#xD;
&#xD;
          5. Patients who have received any radiotherapy or chemotherapy and other anti-tumor&#xD;
             treatment within 4 weeks of the first dose of the study drug, traditional Chinese&#xD;
             medicine with anti-tumor indications within 4 weeks of the first dose of the study&#xD;
             drug, or small molecule targeted drugs within 2 weeks (or 5 half-lives whichever is&#xD;
             longer) of the first dose of the study drug;&#xD;
&#xD;
          6. Patients who currently enrolled in any other clinical study, or received other&#xD;
             investigational agents within 4 weeks of the first dose of the study drug；&#xD;
&#xD;
          7. Blood donation or massive blood loss (&gt;400mL) within 90 days of screening;&#xD;
&#xD;
          8. Concomitant use of strong CYP3A4 inhibitors or inducers, or UGT1A1 inhibitors within 4&#xD;
             weeks of the first dose of the study drug;&#xD;
&#xD;
          9. Patients who received certain diet (such as grapefruit) which may interfere with the&#xD;
             evaluation of PK results;&#xD;
&#xD;
         10. LVEF≤50%;&#xD;
&#xD;
         11. Patients with extended QT/QTc interval (QTcF&gt;480ms);&#xD;
&#xD;
         12. History of alcohol or drugs abuse;&#xD;
&#xD;
         13. Pregnant or lactating women;&#xD;
&#xD;
         14. Patients with known Hepatitis B Virus (HBV DNA≥104), Hepatitis C Virus (anti-HCV&#xD;
             positive, HCV RNA positive), Human immunodeficiency virus antibody (anti-HIV&#xD;
             positive), or active Treponema Pallidum viral infection;&#xD;
&#xD;
         15. Patients with homozygous UGT1A1*28 genotype or UGT1A1*6 genotype;&#xD;
&#xD;
         16. Patients who are not suitable for this study as determined by the researchers.&#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>Jihui Hao, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tianjin Cancer Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>xuekun Yao</last_name>
    <phone>0311-67808678</phone>
    <email>yaoxuekun@mail.ecspc.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tianjin Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tianqiang Song</last_name>
      <phone>022-23340123</phone>
      <phone_ext>6012</phone_ext>
      <email>ec_tjcih@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</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>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irinotecan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04482257
org study id: HE072-BE-002
nct id: NCT04482257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover Bioequivalence Trial
      of Irinotecan Liposome Injection in Patients With Advanced Pancreatic Cancer.
The purpose of this study was to determine the bioequivalence of two formulations of
      Irinotecan Liposome Injection (70mg/m2) in Chinese patients with Advanced Pancreatic Cancer,
      under fasting condition. These data were to be evaluated statistically to determine if the
      products meet bioequivalence criteria.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax
time frame: 0 -190 hours
description: Cmax of Total Irinotecan and Free Irinotecan will be measured for the test product (CSPC) or the reference product (Ipsen).
measure: AUC0-t
time frame: 0 -190 hours
description: The exposure of Total Irinotecan and Free Irinotecan from time (0) to the last quantifiable concentration (t) will be measured for the test product (CSPC) or the reference product (Ipsen).
measure: AUC0-∞
time frame: 0 -190 hours
description: The exposure of Total Irinotecan and Free Irinotecan from time (0) to infinity (∞) will be calculated for the test product (CSPC) or the reference product (Ipsen).
measure: Tmax
time frame: 0 -190 hours
description: The time to maximum concentration will be measured for the test product (CSPC) or the reference product (Ipsen).
measure: t1/2
time frame: 0 -190 hours
description: The terminal elimination half-life will be calculated for the test product (CSPC) or the reference product (Ipsen).
measure: λz
time frame: 0 -190 hours
description: The terminal elimination rate constant will be calculated for the test product (CSPC) or the reference product (Ipsen).
arm group label: T-R
arm group type: Experimental
description: Subjects will receive Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV
arm group label: R-T
arm group type: Experimental
description: Subjects will receive Irinotecan Liposome Injection (Ipsen) 70mg/m2 plus 5-FU/LV, followed by Irinotecan Liposome Injection (CSPC) 70mg/m2 plus 5-FU/LV
intervention type: Drug
intervention name: Irinotecan Liposome Injection combined with 5-FU/LV
description: Drug: Irinotecan Liposome Injection 70mg/m2 (CSPC) combined with 5-FU/LV; Drug: Irinotecan Liposome Injection 70mg/m2 (Ipsen, ONIVYDETM) combined with 5-FU/LV;
arm group label: R-T
arm group label: T-R
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jihui Hao, Ph.D
role: Principal Investigator
affiliation: Tianjin Cancer Hospital
last name: xuekun Yao
phone: 0311-67808678
email: yaoxuekun@mail.ecspc.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Irinotecan
sharing ipd: No