<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/NCT01674855</url>
  </required_header>
  <id_info>
    <org_study_id>DA3031_NP_III</org_study_id>
    <nct_id>NCT01674855</nct_id>
  </id_info>
  <brief_title>Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia</brief_title>
  <acronym>PEG-G-CSF</acronym>
  <official_title>Randomized, Open, Multi-Center, Phase III Study to Evaluate Efficacy and Safety in Chemotherapy-induced Neutropenia of Once-per-cycle DA-3031(PEG-G-CSF) and Daily G-CSF in Patients With Malignancies Receiving Myelosuppressive Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A ST Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong-A ST Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily&#xD;
      G-CSF in chemotherapy-induced neutropenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily&#xD;
      G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle&#xD;
      is repeated every 21 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of grade 4 neutropenia in cycle 1</measure>
    <time_frame>21 day</time_frame>
    <description>Grade 4 neutropenia means the ANC count is less than 500/mm3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ANC nadir in cycle 1</measure>
    <time_frame>21 day</time_frame>
    <description>ANC nadir means the lowest point of ANC count.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to ANC recovery in cycle 1</measure>
    <time_frame>21 day</time_frame>
    <description>ANC recovery means the ANC count is more than 2,000/mm3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of febrile neutropenia</measure>
    <time_frame>126 day</time_frame>
    <description>Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of IV antibiotics administration</measure>
    <time_frame>126 day</time_frame>
    <description>IV antibiotics administration means that antibiotics are administered through intravenous route.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Chemotherapy Induced Neutropenia</condition>
  <arm_group>
    <arm_group_label>DA-3031</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PEG-G-CSF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Leucostim®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>G-CSF</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG-G-CSF</intervention_name>
    <description>Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle</description>
    <arm_group_label>DA-3031</arm_group_label>
    <other_name>DA-3031</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>G-CSF</intervention_name>
    <description>Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle</description>
    <arm_group_label>Leucostim®</arm_group_label>
    <other_name>Leucostim®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age : ≥18, ≤70&#xD;
&#xD;
          2. Diagnosis of stage II, III or IV breast cancer&#xD;
&#xD;
          3. ANC≥1,500/mm3, Platelet≥100,000/mm3, ECOG : 0 or 1&#xD;
&#xD;
          4. Creatinine &lt; 1.5 x ULN&#xD;
&#xD;
          5. Total bilirubin/AST/ALT &lt; 1.5 x ULN, ALP &lt; 2.5 x ULN&#xD;
&#xD;
          6. Have given a written, informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior chemotherapy&#xD;
&#xD;
          2. Prior bone marrow or stem cell transplantation&#xD;
&#xD;
          3. Other malignancy history within 5 years&#xD;
&#xD;
          4. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors&#xD;
&#xD;
          5. Received any other investigational drugs within 30 days of informed consent date&#xD;
&#xD;
          6. Radiation therapy within 4 weeks of informed consent date&#xD;
&#xD;
          7. Infective symptom before chemotherapy into this study&#xD;
&#xD;
          8. Received systemic antibiotics within 72 hours of randomization into this study.&#xD;
&#xD;
          9. HIV positive&#xD;
&#xD;
         10. Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JaeHong Seo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University GURO hospital</name>
      <address>
        <city>Seoul</city>
        <zip>152-703</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>January 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PEG-G-CSF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01674855
org study id: DA3031_NP_III
nct id: NCT01674855
lead sponsor: 
has dmc: No
This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily
      G-CSF in chemotherapy-induced neutropenia.
Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily
      G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle
      is repeated every 21 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of grade 4 neutropenia in cycle 1
time frame: 21 day
description: Grade 4 neutropenia means the ANC count is less than 500/mm3.
measure: ANC nadir in cycle 1
time frame: 21 day
description: ANC nadir means the lowest point of ANC count.
measure: Time to ANC recovery in cycle 1
time frame: 21 day
description: ANC recovery means the ANC count is more than 2,000/mm3.
measure: Incidence of febrile neutropenia
time frame: 126 day
description: Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.3 degrees celsius.
measure: Incidence of IV antibiotics administration
time frame: 126 day
description: IV antibiotics administration means that antibiotics are administered through intravenous route.
arm group label: DA-3031
arm group type: Experimental
description: PEG-G-CSF
arm group label: Leucostim®
arm group type: Active Comparator
description: G-CSF
intervention type: Drug
intervention name: PEG-G-CSF
description: Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
arm group label: DA-3031
other name: DA-3031
intervention type: Drug
intervention name: G-CSF
description: Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle
arm group label: Leucostim®
other name: Leucostim®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: JaeHong Seo, M.D.
role: Principal Investigator
affiliation: Korea University Guro Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Neutropenia
mesh term: Lenograstim