<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/NCT04460820</url>
  </required_header>
  <id_info>
    <org_study_id>DRBX201901/PRO</org_study_id>
    <nct_id>NCT04460820</nct_id>
  </id_info>
  <brief_title>A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection</brief_title>
  <official_title>A Randomized,Open-label, Single-Dose,Two-Cycle,Crossover Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSPC ZhongQi Pharmaceutical Technology 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>
      A Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin&#xD;
      Hydrochloride Liposome Injection Under Advanced Breast Cancers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection , 20 mg:10 mL (CSPC OuYi&#xD;
      Pharmaceutical Technology Co, Ltd), and Caelyx®, 20 mg:10 mL (Janssen-Cilag International&#xD;
      NV), in Advanced Breast Cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2019</start_date>
  <completion_date type="Actual">December 23, 2019</completion_date>
  <primary_completion_date type="Actual">December 23, 2019</primary_completion_date>
  <phase>N/A</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>up to 15 days post-adminstration</time_frame>
    <description>The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>up to 15 days post-adminstration</time_frame>
    <description>The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>up to 15 days post-adminstration</time_frame>
    <description>The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Bioequivalence</condition>
  <arm_group>
    <arm_group_label>Doxorubicin Hydrochloride Liposome Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50mg/m2 ,IV on Day 1 of each cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Doxorubicin Hydrochloride Liposome Injection(Caelyx®)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50mg/m2 ,IV on Day 1 of each cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin Hydrochloride Liposome Injection</intervention_name>
    <description>50mg/m2,IV on Day 1 of each cycle</description>
    <arm_group_label>Doxorubicin Hydrochloride Liposome Injection</arm_group_label>
    <arm_group_label>Doxorubicin Hydrochloride Liposome Injection(Caelyx®)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Voluntary agreement to provide written informed consent. 2.Patients with locally&#xD;
             advanced or metastatic breast cancer diagnosed by histology or cytology，and who may&#xD;
             benefit from monotherapy of Doxorubicin liposomes.&#xD;
&#xD;
             3.Females age 18 to 75 years, inclusive. 4.Body weight ≥45.0 kg, and BSA&lt;1.80m2. 5.The&#xD;
             ECOG performance status is 0 to 2. 6.The expected survival time is more than 3 months.&#xD;
             7.Subjects must have laboratory values within the limits described below: ANC ≥1.5 x&#xD;
             109/L PLT ≥100 x 109/L HB ≥90 g/L PT/INR and APTT ≤1.5 x ULN Cr ≤1.5 x ULN Serum total&#xD;
             bilirubin ≤1.5 x ULN(OR ≤3 X ULN for subjects with liver metastases) AST (SGOT) and&#xD;
             ALT (SGPT) ≤2.5 x ULN (OR ≤5 X ULN for subjects with liver metastases) 8.The subjects&#xD;
             had no pregnancy plan and volunteered to use effective contraception and had no egg&#xD;
             donation plan within 6 months after entering the study.&#xD;
&#xD;
             9.The subject will be able to communicate well with the investigator and understand&#xD;
             and comply with the requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Significant allergy, hypersensitivity or idiosyncratic reactions to doxorubicin&#xD;
             and/or any related compounds.&#xD;
&#xD;
             2.Treatments were terminated due to treatment failure or serious adverse reactions in&#xD;
             subjects who had previously used doxorubicin liposomes.&#xD;
&#xD;
             3.Patients with severe cardiovascular, lung, liver, kidney, gastrointestinal,&#xD;
             endocrine, immune system, skin, musculoskeletal, neurological or psychiatric&#xD;
             conditions that the researchers did not consider appropriate for inclusion.&#xD;
&#xD;
             4.Patients who had undergone major surgery within 3 months before screening, or&#xD;
             planned to undergo major surgery during the study period.&#xD;
&#xD;
             5.Having a history of alcoholism, drug abuse or drug abuse. 6.The results of alcohol&#xD;
             breath test were more than 0.0mg/100ml or drug abuse screening was positive&#xD;
             (Methamphetamine, ketamine, MDMA,Tetrahydrocannabinol).&#xD;
&#xD;
             7.Pregnant or breast-feeding female. 8.Positive result to any of the following:&#xD;
             HIV-1/2, hepatitis B and C; syphilis.&#xD;
&#xD;
             9.Study drug prior to radiation or the use of chemotherapy drugs less than 28 days, or&#xD;
             other antineoplastic therapy (e.g., endocrine therapy, Chinese medicine treatment, the&#xD;
             local radiotherapy of pain relief, etc.) is less than 14 days, or during the study&#xD;
             period need to merge the other anti-tumor drug treatment.&#xD;
&#xD;
             10.Impaired cardiac function: QTc&gt;470ms; LVEF（left ventricular ejection fraction）&#xD;
             below 50% or below institutional normal at screening; Congestive heart failure of&#xD;
             grade≥ 2 from NYHA classification, myocardial infarction or uncontrolled angina&#xD;
             pectoris occurred within 6 months before enrollment; Have had bypass surgery; 11.&#xD;
             Blood donation or massive blood loss within 90 days before screening (&gt; 400ml) .&#xD;
&#xD;
             12.The total cumulative dose of doxorubicin was ≥300mg/m2 before screening, or&#xD;
             previous administration of anthracycline caused severe cardiotoxicity.&#xD;
&#xD;
             13.Eating a specific diet (such as grapefruit) within 48 hours prior to enrollment can&#xD;
             affect drug absorption, distribution, metabolism, and excretion.&#xD;
&#xD;
             14.Participating in other clinical trials and accepting clinical trial drugs within 28&#xD;
             days prior to enrollment.&#xD;
&#xD;
             15.Other researchers judged unsuitable for participation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</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/NCT04460820
org study id: DRBX201901/PRO
nct id: NCT04460820
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin
      Hydrochloride Liposome Injection Under Advanced Breast Cancers.
Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection , 20 mg:10 mL (CSPC OuYi
      Pharmaceutical Technology Co, Ltd), and Caelyx®, 20 mg:10 mL (Janssen-Cilag International
      NV), in Advanced Breast Cancers.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cmax
time frame: up to 15 days post-adminstration
description: The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
measure: AUC
time frame: up to 15 days post-adminstration
description: The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
measure: Tmax
time frame: up to 15 days post-adminstration
description: The pharmacokinetics(PK) profile of Doxorubicin Hydrochloride Liposome Injection
arm group label: Doxorubicin Hydrochloride Liposome Injection
arm group type: Experimental
description: 50mg/m2 ,IV on Day 1 of each cycle
arm group label: Doxorubicin Hydrochloride Liposome Injection(Caelyx®)
arm group type: Active Comparator
description: 50mg/m2 ,IV on Day 1 of each cycle
intervention type: Drug
intervention name: Doxorubicin Hydrochloride Liposome Injection
description: 50mg/m2,IV on Day 1 of each cycle
arm group label: Doxorubicin Hydrochloride Liposome Injection
arm group label: Doxorubicin Hydrochloride Liposome Injection(Caelyx®)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin