<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/NCT03246009</url>
  </required_header>
  <id_info>
    <org_study_id>RG01N-1399</org_study_id>
    <nct_id>NCT03246009</nct_id>
  </id_info>
  <brief_title>Fusion Protein rHSA/GCSFclinical Study on Breast Cancer Patients</brief_title>
  <official_title>Efficacy and Safety Phase Ib Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin SinoBiotech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin SinoBiotech 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>
      The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast&#xD;
      cancer patients with different doses and multiple injections.&#xD;
&#xD;
      To observe the pharmacokinetic characteristics of recombinant human serum albumin&#xD;
      /granulocyte colony-stimulating factor fusion protein after single and multiple&#xD;
      administration&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This experiment adopts the method of multicenter, open, dose escalation study injection with&#xD;
      recombinant human blood clean protein/granulocyte stimulating factor fusion protein after&#xD;
      single and multiple doses of tolerance, security, and pharmacokinetic characteristics.&#xD;
&#xD;
      Breast cancer patients with reduced white blood cells after chemotherapy were selected as&#xD;
      subjects of this study.&#xD;
&#xD;
      The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg&#xD;
      respectively, each of which was studied by single and multiple doses.&#xD;
&#xD;
      Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2016</start_date>
  <completion_date type="Actual">April 10, 2017</completion_date>
  <primary_completion_date type="Actual">April 10, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>14 days</time_frame>
    <description>Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC</measure>
    <time_frame>14 days</time_frame>
    <description>AUC after single and multiple dose of rHSA/GCSF</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Chemotherapy-induced Neutropenia</condition>
  <condition>Cancer, Breast</condition>
  <arm_group>
    <arm_group_label>single injection-1.8mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>single injection-2.1mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>single injection-2.4mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>multiple injection-1.8mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>multiple injection-2.1mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>multiple injection-2.4mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rHSA/GCSF</intervention_name>
    <description>single injection-1.8mg</description>
    <arm_group_label>single injection-1.8mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rHSA/GCSF</intervention_name>
    <description>single injection-2.1mg</description>
    <arm_group_label>single injection-2.1mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rHSA/GCSF</intervention_name>
    <description>single injection-2.4mg</description>
    <arm_group_label>single injection-2.4mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rHSA/GCSF</intervention_name>
    <description>multiple injection-1.8mg</description>
    <arm_group_label>multiple injection-1.8mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rHSA/GCSF</intervention_name>
    <description>multiple injection-2.1mg</description>
    <arm_group_label>multiple injection-2.1mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rHSA/GCSF</intervention_name>
    <description>multiple injection-2.4mg</description>
    <arm_group_label>multiple injection-2.4mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65.&#xD;
&#xD;
          -  Diagnosed breast cancer，received chemotherapy.&#xD;
&#xD;
          -  ECOG performance status 0 or 1.&#xD;
&#xD;
          -  ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function&#xD;
             normally, no Hemorrhagic tendency.&#xD;
&#xD;
          -  Leukocyte reduction occurred after chemotherapy,WBC≤3.0x109/L or ANC≤1.5x109/L.&#xD;
&#xD;
          -  No obvious abnormal ecg examination.&#xD;
&#xD;
          -  Cr，TBIL, AST, ALT≤1.5×ULN，no serious underlying disease.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemotherapy within past 4 weeks.&#xD;
&#xD;
          -  Uncontrolled inflammatory disease,axillary temperature≥38℃.&#xD;
&#xD;
          -  Merging other malignant tumor.&#xD;
&#xD;
          -  Pregnancy or nursing status.&#xD;
&#xD;
          -  Participation in another clinical trial with and investigational product within 3&#xD;
             months prior to study entry.&#xD;
&#xD;
          -  Severe diabetes mellitus, or poor blood sugar controller.&#xD;
&#xD;
          -  Allergic disease or allergic constitution. History of protein allergy.&#xD;
&#xD;
          -  History of drug addiction and alcoholism.&#xD;
&#xD;
          -  Hematopoietic stem cell transplantation or organ transplantation.&#xD;
&#xD;
          -  Received antibiotic treatment within 72 hours before chemotherapy.&#xD;
&#xD;
          -  Long-term use of hormones or immunosuppressive agents.&#xD;
&#xD;
          -  Severe mental or neurological disorders.&#xD;
&#xD;
          -  Chronic disease of severe cardiac, kidney and liver.&#xD;
&#xD;
          -  Other conditions that would be excluded from this study according to doctors'judgment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Binghe XU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>chinese academy of medical sciences tumor hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neutropenia</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>rHSA/GCSF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neutropenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</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/NCT03246009
org study id: RG01N-1399
nct id: NCT03246009
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the tolerance and safety of the rHSA/GCSF in breast
      cancer patients with different doses and multiple injections.

      To observe the pharmacokinetic characteristics of recombinant human serum albumin
      /granulocyte colony-stimulating factor fusion protein after single and multiple
      administration
This experiment adopts the method of multicenter, open, dose escalation study injection with
      recombinant human blood clean protein/granulocyte stimulating factor fusion protein after
      single and multiple doses of tolerance, security, and pharmacokinetic characteristics.

      Breast cancer patients with reduced white blood cells after chemotherapy were selected as
      subjects of this study.

      The three research doses that were to be incremented were 1.8 mg, 2.1mg and 2.4mg
      respectively, each of which was studied by single and multiple doses.

      Single dose of medicine, dose-climbing study.Two doses of the drug, dose-climbing study
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of adverse events
time frame: 14 days
description: Number of participants with AE as a measure for safety and tolerability after single and multiple dose of rHSA/GCSF
measure: AUC
time frame: 14 days
description: AUC after single and multiple dose of rHSA/GCSF
arm group label: single injection-1.8mg
arm group type: Experimental
description: rHSA/GCSF,injection,1.8mg,Single subcutaneous injection,Duration 1 day
arm group label: single injection-2.1mg
arm group type: Experimental
description: rHSA/GCSF,injection,2.1mg,Single subcutaneous injection,Duration 1 day
arm group label: single injection-2.4mg
arm group type: Experimental
description: rHSA/GCSF,injection,2.4mg,Single subcutaneous injection,Duration 1 day
arm group label: multiple injection-1.8mg
arm group type: Experimental
description: rHSA/GCSF,injection,1.8mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
arm group label: multiple injection-2.1mg
arm group type: Experimental
description: rHSA/GCSF,injection,2.1mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
arm group label: multiple injection-2.4mg
arm group type: Experimental
description: rHSA/GCSF,injection,2.4mg, subcutaneous injection,Duration 4 day,A total of 2 injections, each interval of 3 days.
intervention type: Drug
intervention name: rHSA/GCSF
description: single injection-1.8mg
arm group label: single injection-1.8mg
intervention type: Drug
intervention name: rHSA/GCSF
description: single injection-2.1mg
arm group label: single injection-2.1mg
intervention type: Drug
intervention name: rHSA/GCSF
description: single injection-2.4mg
arm group label: single injection-2.4mg
intervention type: Drug
intervention name: rHSA/GCSF
description: multiple injection-1.8mg
arm group label: multiple injection-1.8mg
intervention type: Drug
intervention name: rHSA/GCSF
description: multiple injection-2.1mg
arm group label: multiple injection-2.1mg
intervention type: Drug
intervention name: rHSA/GCSF
description: multiple injection-2.4mg
arm group label: multiple injection-2.4mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Binghe XU, MD
role: Principal Investigator
affiliation: chinese academy of medical sciences tumor hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neutropenia
mesh term: Lenograstim