<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/NCT03252431</url>
  </required_header>
  <id_info>
    <org_study_id>GC-627-05</org_study_id>
    <nct_id>NCT03252431</nct_id>
  </id_info>
  <brief_title>Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy</brief_title>
  <official_title>A Phase III, Randomized, Multi-Centre, Open-Label, Fixed Dose, Neulasta® Active-Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EVIVE Biotechnology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EVIVE Biotechnology</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3&#xD;
      study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive&#xD;
      breast cancer receiving chemotherapy treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase III, global, two arm, open label clinical study will randomize approximately&#xD;
      400 female subjects (approximately 200 per arm) with Stage I - III invasive breast cancer who&#xD;
      are to receive neoadjuvant or adjuvant myelotoxic TC chemotherapy treatment (docetaxel +&#xD;
      cyclophosphamide, 75 and 600 mg/m2, respectively). Subjects in this study will be those who&#xD;
      are scheduled to undergo at least four 21-day cycles of chemotherapy treatment. Subjects may&#xD;
      be scheduled for more than 4 cycles of chemotherapy; however, study participation will be&#xD;
      limited to a subject's first 4 cycles.&#xD;
&#xD;
      The primary objective of this study will be to evaluate the efficacy of F-627 given as a&#xD;
      single fixed dose (20 mg) pre-filled syringe as compared to Neulasta® standard dosing (6 mg)&#xD;
      in the first chemotherapy cycle. The primary endpoint will be the duration of grade 4&#xD;
      (severe) neutropenia - the number of days in which the patient has had an absolute neutrophil&#xD;
      count (ANC &lt;0.5 x 10^9/L) observed in chemotherapy cycle 1.&#xD;
&#xD;
      Approximately 24 hours after chemotherapy completion in each cycle (Day 2 of the cycle),&#xD;
      subjects will receive one of the following treatments:&#xD;
&#xD;
      Arm 1: F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4&#xD;
      chemotherapy cycles.&#xD;
&#xD;
      Arm 2: 6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
      Randomization will occur in an equal ratio (1:1) using a central randomization system (IWRS)&#xD;
      on Day 1 of the study, the day of chemotherapy administration for the first chemotherapy&#xD;
      cycle.&#xD;
&#xD;
      This study is open-label, however, study drug injections are to be administered separately by&#xD;
      qualified study personnel to allow study investigators to remain blinded and perform study&#xD;
      assessments without knowledge of treatment assignment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2018</start_date>
  <completion_date type="Actual">March 5, 2020</completion_date>
  <primary_completion_date type="Actual">September 25, 2019</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1</measure>
    <time_frame>The first of 4, 21-day chemotherapy cycles (average 3 weeks)</time_frame>
    <description>Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC &lt;0.5 × 109/L within the first 12 days of chemotherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration in Days of Use of Intravenous Antibiotic</measure>
    <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
    <description>The duration of use of IV antibiotics was defined as the number of days in which IV antibiotics were administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration in Days of Hospitalization</measure>
    <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
    <description>The duration in days of patients been hospitalized for febrile neutropenia (FN) or any infection. Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of &gt;38.0°C (100.4°F) sustained for &gt;1 hour and ANC &lt;0.5 x 10^9/L on the same day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1</measure>
    <time_frame>The first of 4, 21-day chemotherapy cycles (average 3 weeks)</time_frame>
    <description>The number of participants with grade 4 neutropenia for chemotherapy cycle 1. Grade 4 (severe) neutropenia was defined as ANC &lt;0.5 × 109/L within the first 12 days of chemotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Febrile Neutropenia Considering All Chemotherapy Cycles.</measure>
    <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
    <description>The number of participants with febrile neutropenia, considering all chemotherapy cycles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With Use of IV Antibiotics Considering All Chemotherapy Cycles.</measure>
    <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
    <description>The number of participants with use of IV antibiotics, considering all chemotherapy cycles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants in Hospitalization for Febrile Neutropenia or Any Infection Considering All Chemotherapy Cycles</measure>
    <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
    <description>The number of participants in hospitalization for febrile neutropenia or any infection, .</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">393</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Neutropenia</condition>
  <arm_group>
    <arm_group_label>F-627</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neulasta</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>F-627</intervention_name>
    <description>single dose pre-filled syringe</description>
    <arm_group_label>F-627</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neulasta</intervention_name>
    <description>single dose pre-filled syringe</description>
    <arm_group_label>Neulasta</arm_group_label>
    <other_name>pegfilgrastim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Show evidence of a personally signed and dated informed consent document indicating&#xD;
             that the patient has been informed of all pertinent aspects of the trial.&#xD;
&#xD;
          2. Females ≥18 years of age.&#xD;
&#xD;
          3. Diagnosed with Stage I-III breast cancer.&#xD;
&#xD;
          4. Subject is scheduled to undergo 4 cycles of neoadjuvant or adjuvant TC chemotherapy&#xD;
             (docetaxel, cyclophosphamide, 75, 600 mg/m2, respectively).&#xD;
&#xD;
          5. ECOG Performance status of ≤2.&#xD;
&#xD;
          6. WBC count ≥4.0 × 109/L, hemoglobin ≥11.5 g/dL and a platelet count ≥150 × 109/L.&#xD;
&#xD;
          7. Demonstrate adequate renal, hepatic, and cardiac function (liver function tests&#xD;
             [alanine aminotransferase {ALT}, aspartate aminotransferase {AST}, alkaline&#xD;
             phosphatase, and total bilirubin]) should be less than 2.5x the upper limits of normal&#xD;
             (ULN). Serum creatinine should be less than 1.7x ULN.&#xD;
&#xD;
          8. All subjects must agree to use at least one of the following types of contraception:&#xD;
             intrauterine device, implantable progesterone device, progesterone intramuscular&#xD;
             injection, or oral contraceptive, which has been started at least one month prior to&#xD;
             visit one and will continue for the duration of the trial. The contraceptive patch or&#xD;
             condom use with spermicide is also acceptable forms of contraception as long as they&#xD;
             will be used continually throughout the duration of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is &lt;18 years of age.&#xD;
&#xD;
          2. Disease progression has occurred while receiving a taxane regimen.&#xD;
&#xD;
          3. Subject has undergone radiation therapy within 4 weeks of enrollment.&#xD;
&#xD;
          4. Subject has undergone bone marrow or stem-cell transplantation.&#xD;
&#xD;
          5. Subject has a history of prior malignancy other than breast cancer that is NOT in&#xD;
             remission.&#xD;
&#xD;
          6. Subjects that have used G-CSF or any other drug that may potentiate the release of&#xD;
             neutrophils (i.e., lithium) within 6 weeks of the screening period are excluded.&#xD;
&#xD;
          7. Subject has had chemotherapy within 180 days of screening.&#xD;
&#xD;
          8. Subject has documented congestive heart failure, cardiomyopathy or myocardial&#xD;
             infarction by clinical diagnosis, electrocardiogram (ECG) test, or any other relevant&#xD;
             test.&#xD;
&#xD;
          9. History of alcohol or drug abuse that would interfere with the ability to be compliant&#xD;
             with the study procedure.&#xD;
&#xD;
         10. Unwillingness to participate in the study.&#xD;
&#xD;
         11. Any underlying medical condition that, in the Investigator's opinion, would make the&#xD;
             administration of study drug hazardous to the patient or that would obscure the&#xD;
             interpretation of adverse events.&#xD;
&#xD;
         12. Receiving other investigational drugs or biologics within 1 month or five half lives&#xD;
             of enrollment (if known), which ever is less.&#xD;
&#xD;
         13. Any condition, which can cause splenomegaly.&#xD;
&#xD;
         14. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel&#xD;
             disease.&#xD;
&#xD;
         15. ALT, AST, alkaline phosphatase, total bilirubin ≥2.5x ULN.&#xD;
&#xD;
         16. Subject with active infection, or known to be infected with chronic active Hepatitis B&#xD;
             within the last 1 year (unless shown at the time of study entry to be Hepatitis B&#xD;
             antigen negative), or having any history of Hepatitis C.&#xD;
&#xD;
         17. Women who are pregnant or breast-feeding.&#xD;
&#xD;
         18. Subject known to be seropositive for HIV, or who have had an AIDS defining illness or&#xD;
             a known immunodeficiency disorder.&#xD;
&#xD;
         19. Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have&#xD;
             received a prior chest X-ray for suspicion of tuberculosis are also excluded unless&#xD;
             they have been confirmed to be PPD negative or they had latent tuberculosis that has&#xD;
             been previously treated.&#xD;
&#xD;
         20. Subjects with Sickle Cell disease&#xD;
&#xD;
         21. Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim'&#xD;
             filgrastim, or any other component of the study drug.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Glaspy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California at Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Los Angeles (UCLA) - Jonsson Comprehensive Cancer Center (JCCC)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <results_first_submitted>January 4, 2021</results_first_submitted>
  <results_first_submitted_qc>April 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 7, 2021</results_first_posted>
  <last_update_submitted>June 28, 2023</last_update_submitted>
  <last_update_submitted_qc>June 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</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>Breast Neoplasms</mesh_term>
    <mesh_term>Neutropenia</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03252431/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03252431/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>F-627</title>
          <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
        </group>
        <group group_id="P2">
          <title>Neulasta</title>
          <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
                <participants group_id="P2" count="196"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="186"/>
                <participants group_id="P2" count="187"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>F-627</title>
          <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
        </group>
        <group group_id="B2">
          <title>Neulasta</title>
          <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="197"/>
            <count group_id="B2" value="196"/>
            <count group_id="B3" value="393"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.4" spread="11.82"/>
                    <measurement group_id="B2" value="53.4" spread="11.11"/>
                    <measurement group_id="B3" value="52.4" spread="11.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="196"/>
                    <measurement group_id="B3" value="393"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="195"/>
                    <measurement group_id="B3" value="392"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="196"/>
                    <measurement group_id="B3" value="393"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.84" spread="16.884"/>
                    <measurement group_id="B2" value="74.93" spread="16.873"/>
                    <measurement group_id="B3" value="75.39" spread="16.863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="162.6" spread="6.27"/>
                    <measurement group_id="B2" value="162.2" spread="6.67"/>
                    <measurement group_id="B3" value="162.4" spread="6.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Basal Metabolic Index</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.72" spread="6.358"/>
                    <measurement group_id="B2" value="28.51" spread="6.197"/>
                    <measurement group_id="B3" value="28.62" spread="6.271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1</title>
        <description>Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC &lt;0.5 × 109/L within the first 12 days of chemotherapy.</description>
        <time_frame>The first of 4, 21-day chemotherapy cycles (average 3 weeks)</time_frame>
        <population>ITT (Intent-to-Treat) population</population>
        <group_list>
          <group group_id="O1">
            <title>F-627</title>
            <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
          </group>
          <group group_id="O2">
            <title>Neulasta</title>
            <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1</title>
          <description>Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC &lt;0.5 × 109/L within the first 12 days of chemotherapy.</description>
          <population>ITT (Intent-to-Treat) population</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.51"/>
                    <measurement group_id="O2" value="0.2" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration in Days of Use of Intravenous Antibiotic</title>
        <description>The duration of use of IV antibiotics was defined as the number of days in which IV antibiotics were administered</description>
        <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
        <population>ITT (Intent-to-Treat) population</population>
        <group_list>
          <group group_id="O1">
            <title>F-627</title>
            <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
          </group>
          <group group_id="O2">
            <title>Neulasta</title>
            <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Duration in Days of Use of Intravenous Antibiotic</title>
          <description>The duration of use of IV antibiotics was defined as the number of days in which IV antibiotics were administered</description>
          <population>ITT (Intent-to-Treat) population</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.36"/>
                    <measurement group_id="O2" value="0.1" spread="0.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration in Days of Hospitalization</title>
        <description>The duration in days of patients been hospitalized for febrile neutropenia (FN) or any infection. Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of &gt;38.0°C (100.4°F) sustained for &gt;1 hour and ANC &lt;0.5 x 10^9/L on the same day.</description>
        <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
        <population>ITT (Intent-to-Treat) population</population>
        <group_list>
          <group group_id="O1">
            <title>F-627</title>
            <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
          </group>
          <group group_id="O2">
            <title>Neulasta</title>
            <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
          </group>
        </group_list>
        <measure>
          <title>Duration in Days of Hospitalization</title>
          <description>The duration in days of patients been hospitalized for febrile neutropenia (FN) or any infection. Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of &gt;38.0°C (100.4°F) sustained for &gt;1 hour and ANC &lt;0.5 x 10^9/L on the same day.</description>
          <population>ITT (Intent-to-Treat) population</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.78"/>
                    <measurement group_id="O2" value="0" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1</title>
        <description>The number of participants with grade 4 neutropenia for chemotherapy cycle 1. Grade 4 (severe) neutropenia was defined as ANC &lt;0.5 × 109/L within the first 12 days of chemotherapy.</description>
        <time_frame>The first of 4, 21-day chemotherapy cycles (average 3 weeks)</time_frame>
        <population>ITT (Intent-to-Treat) population</population>
        <group_list>
          <group group_id="O1">
            <title>F-627</title>
            <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
          </group>
          <group group_id="O2">
            <title>Neulasta</title>
            <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1</title>
          <description>The number of participants with grade 4 neutropenia for chemotherapy cycle 1. Grade 4 (severe) neutropenia was defined as ANC &lt;0.5 × 109/L within the first 12 days of chemotherapy.</description>
          <population>ITT (Intent-to-Treat) population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Febrile Neutropenia Considering All Chemotherapy Cycles.</title>
        <description>The number of participants with febrile neutropenia, considering all chemotherapy cycles.</description>
        <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
        <population>ITT (Intent-to-Treat) population</population>
        <group_list>
          <group group_id="O1">
            <title>F-627</title>
            <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
          </group>
          <group group_id="O2">
            <title>Neulasta</title>
            <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Febrile Neutropenia Considering All Chemotherapy Cycles.</title>
          <description>The number of participants with febrile neutropenia, considering all chemotherapy cycles.</description>
          <population>ITT (Intent-to-Treat) population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With Use of IV Antibiotics Considering All Chemotherapy Cycles.</title>
        <description>The number of participants with use of IV antibiotics, considering all chemotherapy cycles.</description>
        <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
        <population>ITT (Intent-to-Treat) population</population>
        <group_list>
          <group group_id="O1">
            <title>F-627</title>
            <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
          </group>
          <group group_id="O2">
            <title>Neulasta</title>
            <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With Use of IV Antibiotics Considering All Chemotherapy Cycles.</title>
          <description>The number of participants with use of IV antibiotics, considering all chemotherapy cycles.</description>
          <population>ITT (Intent-to-Treat) population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants in Hospitalization for Febrile Neutropenia or Any Infection Considering All Chemotherapy Cycles</title>
        <description>The number of participants in hospitalization for febrile neutropenia or any infection, .</description>
        <time_frame>across all 4 chemotherapy cycles (average 84 days)</time_frame>
        <population>ITT (Intent-to-Treat) population</population>
        <group_list>
          <group group_id="O1">
            <title>F-627</title>
            <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
          </group>
          <group group_id="O2">
            <title>Neulasta</title>
            <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants in Hospitalization for Febrile Neutropenia or Any Infection Considering All Chemotherapy Cycles</title>
          <description>The number of participants in hospitalization for febrile neutropenia or any infection, .</description>
          <population>ITT (Intent-to-Treat) population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs and SAEs were collected from the time of randomization until end of treatment visit day 84 (total of 9 months).</time_frame>
      <desc>Treatment emergent AE was defined as any AE that began on or after study drug (F-627 or Neulasta) treatment up to the EOT visit or was a worsening of a pre-existing medical condition.</desc>
      <group_list>
        <group group_id="E1">
          <title>F-627</title>
          <description>F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.&#xD;
F-627: single dose pre-filled syringe</description>
        </group>
        <group group_id="E2">
          <title>Neulasta</title>
          <description>6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles&#xD;
Neulasta: single dose pre-filled syringe</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis toxic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>angioedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="58" subjects_affected="14" subjects_at_risk="197"/>
                <counts group_id="E2" events="39" subjects_affected="10" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="26" subjects_affected="13" subjects_at_risk="197"/>
                <counts group_id="E2" events="18" subjects_affected="12" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="54" subjects_affected="31" subjects_at_risk="197"/>
                <counts group_id="E2" events="44" subjects_affected="23" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="197"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christina Tay</name_or_title>
      <organization>Generon/Evive Biotech</organization>
      <phone>1-908-540-0816</phone>
      <email>christina.tay@evivebiotech.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03252431
org study id: GC-627-05
nct id: NCT03252431
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3
      study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive
      breast cancer receiving chemotherapy treatment.
This is a Phase III, global, two arm, open label clinical study will randomize approximately
      400 female subjects (approximately 200 per arm) with Stage I - III invasive breast cancer who
      are to receive neoadjuvant or adjuvant myelotoxic TC chemotherapy treatment (docetaxel +
      cyclophosphamide, 75 and 600 mg/m2, respectively). Subjects in this study will be those who
      are scheduled to undergo at least four 21-day cycles of chemotherapy treatment. Subjects may
      be scheduled for more than 4 cycles of chemotherapy; however, study participation will be
      limited to a subject's first 4 cycles.

      The primary objective of this study will be to evaluate the efficacy of F-627 given as a
      single fixed dose (20 mg) pre-filled syringe as compared to Neulasta® standard dosing (6 mg)
      in the first chemotherapy cycle. The primary endpoint will be the duration of grade 4
      (severe) neutropenia - the number of days in which the patient has had an absolute neutrophil
      count (ANC <0.5 x 10^9/L) observed in chemotherapy cycle 1.

      Approximately 24 hours after chemotherapy completion in each cycle (Day 2 of the cycle),
      subjects will receive one of the following treatments:

      Arm 1: F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4
      chemotherapy cycles.

      Arm 2: 6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
      Randomization will occur in an equal ratio (1:1) using a central randomization system (IWRS)
      on Day 1 of the study, the day of chemotherapy administration for the first chemotherapy
      cycle.

      This study is open-label, however, study drug injections are to be administered separately by
      qualified study personnel to allow study investigators to remain blinded and perform study
      assessments without knowledge of treatment assignment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1
time frame: The first of 4, 21-day chemotherapy cycles (average 3 weeks)
description: Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC <0.5 × 109/L within the first 12 days of chemotherapy.
measure: Duration in Days of Use of Intravenous Antibiotic
time frame: across all 4 chemotherapy cycles (average 84 days)
description: The duration of use of IV antibiotics was defined as the number of days in which IV antibiotics were administered
measure: Duration in Days of Hospitalization
time frame: across all 4 chemotherapy cycles (average 84 days)
description: The duration in days of patients been hospitalized for febrile neutropenia (FN) or any infection. Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of >38.0°C (100.4°F) sustained for >1 hour and ANC <0.5 x 10^9/L on the same day.
measure: The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1
time frame: The first of 4, 21-day chemotherapy cycles (average 3 weeks)
description: The number of participants with grade 4 neutropenia for chemotherapy cycle 1. Grade 4 (severe) neutropenia was defined as ANC <0.5 × 109/L within the first 12 days of chemotherapy.
measure: The Number of Participants With Febrile Neutropenia Considering All Chemotherapy Cycles.
time frame: across all 4 chemotherapy cycles (average 84 days)
description: The number of participants with febrile neutropenia, considering all chemotherapy cycles.
measure: The Number of Participants With Use of IV Antibiotics Considering All Chemotherapy Cycles.
time frame: across all 4 chemotherapy cycles (average 84 days)
description: The number of participants with use of IV antibiotics, considering all chemotherapy cycles.
measure: The Number of Participants in Hospitalization for Febrile Neutropenia or Any Infection Considering All Chemotherapy Cycles
time frame: across all 4 chemotherapy cycles (average 84 days)
description: The number of participants in hospitalization for febrile neutropenia or any infection, .
arm group label: F-627
arm group type: Experimental
description: F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.
arm group label: Neulasta
arm group type: Active Comparator
description: 6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles
intervention type: Drug
intervention name: F-627
description: single dose pre-filled syringe
arm group label: F-627
intervention type: Drug
intervention name: Neulasta
description: single dose pre-filled syringe
arm group label: Neulasta
other name: pegfilgrastim
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Glaspy, MD
role: Principal Investigator
affiliation: University of California at Los Angeles
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neutropenia
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 