<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/NCT03776032</url>
  </required_header>
  <id_info>
    <org_study_id>00980297</org_study_id>
    <nct_id>NCT03776032</nct_id>
  </id_info>
  <brief_title>A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy</brief_title>
  <official_title>A Double-Blind, Placebo Controlled, Randomised Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Lung Cancer Subjects Receiving Multicycle Platinum-Containing Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study was to compare the effectiveness of darbopoetin alfa to&#xD;
      placebo in the treatment of anemia in adults with lung cancer receiving multicycle&#xD;
      platinum-containing chemotherapy, by assessing the percentage of participants who received&#xD;
      red blood cell (RBC) transfusions during weeks 5-12 inclusive.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 1999</start_date>
  <completion_date type="Actual">February 27, 2002</completion_date>
  <primary_completion_date type="Actual">November 8, 2000</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12</measure>
    <time_frame>Weeks 5 to 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to First Red Blood Cell Transfusion During Weeks 5 to 12</measure>
    <time_frame>Week 5 to week 12</time_frame>
    <description>The number of days from the first day of study week 5 (day 29) to the first administration of a RBC transfusion during the Treatment Phase that occurs on or after day 29.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with a Hemoglobin Response by Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>Hemoglobin Response was defined as an increase in hemoglobin of ≥ 2.0 g/dL over baseline hemoglobin in the absence of any RBC transfusions during the preceding 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Hemoglobin Response</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of days from the first administration of study drug to the first occurrence of a hemoglobin response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>Sustained hemoglobin response was defined as in increase in hemoglobin of ≥ 2.0 g/dL over baseline hemoglobin sustained for at least 28 days or until the end of the Treatment Phase. This increase must have occurred in the absence of RBC transfusions during the period of sustained response and the preceding 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Sustained Hemoglobin Response</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieved a Hemoglobin Correction by Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>Hemoglobin correction was defined as a hemoglobin value of ≥ 12.0 g/dL that occurred in the absence of RBC transfusions during the preceding 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieved a Sustained Hemoglobin Correction by Week 12</measure>
    <time_frame>12 weeks</time_frame>
    <description>Sustained hemoglobin correction was defined as a hemoglobin value of ≥ 12.0 g/dL that was sustained for at least 28 days or until the end of the Treatment Phase. This must have occurred in the absence of RBC transfusions during the period of sustained correction and the preceding 28 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Hemoglobin Correction</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of days from the first administration of study drug to the first occurrence of a hemoglobin correction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Sustained Hemoglobin Correction</measure>
    <time_frame>12 weeks</time_frame>
    <description>The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin correction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Hemoglobin at Week 12</measure>
    <time_frame>Baseline and week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Received a Red Blood Cell Transfusion During Weeks 1 to 4, 5 to 8, and 9 to 12</measure>
    <time_frame>Weeks 1 to 4, 5 to 8, and 9 to 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Standard Units of RBCs Transfused During Weeks 5 to 12</measure>
    <time_frame>Weeks 5 to 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days with RBC Transfusions During Weeks 5 to 12</measure>
    <time_frame>Weeks 5 to 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Functional Assessment of Cancer Therapy (FACT)-Anemia Subscales at Week 12</measure>
    <time_frame>Baseline and week 12</time_frame>
    <description>The FACT-anemia is a 47-item questionnaire to assess specific quality of life concerns related to anemia and fatigue in cancer patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Darbepoetin alfa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received once a week darbepoetin alfa, administered by subcutaneous injection at a starting dose of 2.25 µg/kg for up to 12 weeks. The dose of darbepoetin alfa may have been adjusted based on hemoglobin levels to a maximum dose of 4.5 µg/kg /week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received once a week placebo, administered by subcutaneous injection for up to 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Darbepoetin alfa</intervention_name>
    <description>Administered by subcutaneous injection once a week</description>
    <arm_group_label>Darbepoetin alfa</arm_group_label>
    <other_name>Novel Erythropoiesis Stimulating Protein (NESP)</other_name>
    <other_name>Aranesp</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching to darbopoetin alfa administered by subcutaneous injection once a week.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lung cancer (either small cell [SCLC] or non-small cell [NSCLC])&#xD;
&#xD;
          -  At least 12 additional weeks of platinum containing cyclic chemotherapy planned&#xD;
             regardless of cycle length&#xD;
&#xD;
          -  Anemia (hemoglobin ≤ 11.0 g/dL) as assessed by a local or central laboratory result&#xD;
             within 7 days before study day 1 (the first scheduled day of on-study chemotherapy and&#xD;
             the first day of study drug administration)&#xD;
&#xD;
          -  Life expectancy of at least 6 months, and an Eastern Cooperative Oncology Group (ECOG)&#xD;
             performance status of 0, 1, or 2.&#xD;
&#xD;
          -  Anemia predominantly due to the cancer or chemotherapy (i.e.. serum folate ≥ 4.5&#xD;
             nmol/L (≥ 2.0 ng/mL) and vitamin B 12 ≥ 148 pmol/L (≥ 200 pg/mL), no overt hemolysis,&#xD;
             and no overt gastrointestinal bleeding or bleeding due to recent surgery)&#xD;
&#xD;
          -  Adequate renal function (creatinine ≤ 177gmol/L (≤ 2.0 mg/dL) and adequate hepatic&#xD;
             function (bilirubin ≤ 1.5 times central laboratory's upper limit of normal range)&#xD;
&#xD;
          -  Available for 4 weeks post administration of the last dose of study drug&#xD;
&#xD;
          -  Legal age for informed consent, and written informed consent must be obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any primary hematological disorder which could cause anemia (e.g., sickle&#xD;
             cell anemia)&#xD;
&#xD;
          -  Received prior whole pelvis radiation therapy&#xD;
&#xD;
          -  Uncontrolled angina, congestive heart failure (New York Heart Association &gt; class II&#xD;
             or known ejection fraction &lt; 40%)], or uncontrolled cardiac arrhythmia.&#xD;
&#xD;
          -  History of primary or metastatic malignancy involving the central nervous system&#xD;
             (CNS). Subjects with a previous history of primary or metastatic malignancy involving&#xD;
             the CNS will be eligible for the study providing they have had no clinical signs of&#xD;
             nor treatment for CNS disease and no history of seizures within previous 2 years&#xD;
&#xD;
          -  Uncontrolled hypertension (i.e., diastolic blood pressure &gt; 100 mm Hg)&#xD;
&#xD;
          -  History of seizures. Subjects with a previous history of seizures will be eligible for&#xD;
             the study providing they have had no evidence of seizure activity and have been free&#xD;
             of anti-seizure medication for the previous 5 years&#xD;
&#xD;
          -  Evidence of clinically significant systemic active infection or chronic inflammatory&#xD;
             disease (e.g., rheumatoid arthritis)&#xD;
&#xD;
          -  Iron deficiency (transferrin saturation &lt; 15% and ferritin &lt; 10 μg/L (&lt; 10 ng/mL))&#xD;
&#xD;
          -  Received &gt; 2 RBC transfusions within 4 weeks before randomization or any RBC&#xD;
             transfusion within 2 weeks before randomization&#xD;
&#xD;
          -  Received erythropoietin therapy within 8 weeks before randomization&#xD;
&#xD;
          -  Known positive test for human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Receiving, or not yet 30 days past the end of receiving, another investigational agent&#xD;
             or device not approved in any indication.&#xD;
&#xD;
          -  Pregnant or breast feeding females.&#xD;
&#xD;
          -  Not using adequate contraceptive precautions&#xD;
&#xD;
          -  Prior treatment with NESP&#xD;
&#xD;
          -  Previously randomized in this study&#xD;
&#xD;
          -  Known hypersensitivity to mammalian-derived product&#xD;
&#xD;
          -  Concerns for subject's compliance with the protocol procedure, including completion of&#xD;
             the quality of life surveys (QOLS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Darbepoetin alfa</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/NCT03776032
org study id: 00980297
nct id: NCT03776032
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study was to compare the effectiveness of darbopoetin alfa to
      placebo in the treatment of anemia in adults with lung cancer receiving multicycle
      platinum-containing chemotherapy, by assessing the percentage of participants who received
      red blood cell (RBC) transfusions during weeks 5-12 inclusive.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12
time frame: Weeks 5 to 12
measure: Time to First Red Blood Cell Transfusion During Weeks 5 to 12
time frame: Week 5 to week 12
description: The number of days from the first day of study week 5 (day 29) to the first administration of a RBC transfusion during the Treatment Phase that occurs on or after day 29.
measure: Percentage of Participants with a Hemoglobin Response by Week 12
time frame: 12 weeks
description: Hemoglobin Response was defined as an increase in hemoglobin of ≥ 2.0 g/dL over baseline hemoglobin in the absence of any RBC transfusions during the preceding 28 days.
measure: Time to Hemoglobin Response
time frame: 12 weeks
description: The number of days from the first administration of study drug to the first occurrence of a hemoglobin response.
measure: Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12
time frame: 12 weeks
description: Sustained hemoglobin response was defined as in increase in hemoglobin of ≥ 2.0 g/dL over baseline hemoglobin sustained for at least 28 days or until the end of the Treatment Phase. This increase must have occurred in the absence of RBC transfusions during the period of sustained response and the preceding 28 days.
measure: Time to Sustained Hemoglobin Response
time frame: 12 weeks
description: The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin response.
measure: Percentage of Participants who Achieved a Hemoglobin Correction by Week 12
time frame: 12 weeks
description: Hemoglobin correction was defined as a hemoglobin value of ≥ 12.0 g/dL that occurred in the absence of RBC transfusions during the preceding 28 days.
measure: Percentage of Participants who Achieved a Sustained Hemoglobin Correction by Week 12
time frame: 12 weeks
description: Sustained hemoglobin correction was defined as a hemoglobin value of ≥ 12.0 g/dL that was sustained for at least 28 days or until the end of the Treatment Phase. This must have occurred in the absence of RBC transfusions during the period of sustained correction and the preceding 28 days.
measure: Time to Hemoglobin Correction
time frame: 12 weeks
description: The number of days from the first administration of study drug to the first occurrence of a hemoglobin correction.
measure: Time to Sustained Hemoglobin Correction
time frame: 12 weeks
description: The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin correction.
measure: Change from Baseline in Hemoglobin at Week 12
time frame: Baseline and week 12
measure: Percentage of Participants who Received a Red Blood Cell Transfusion During Weeks 1 to 4, 5 to 8, and 9 to 12
time frame: Weeks 1 to 4, 5 to 8, and 9 to 12
measure: Number of Standard Units of RBCs Transfused During Weeks 5 to 12
time frame: Weeks 5 to 12
measure: Number of Days with RBC Transfusions During Weeks 5 to 12
time frame: Weeks 5 to 12
measure: Change from Baseline in the Functional Assessment of Cancer Therapy (FACT)-Anemia Subscales at Week 12
time frame: Baseline and week 12
description: The FACT-anemia is a 47-item questionnaire to assess specific quality of life concerns related to anemia and fatigue in cancer patients.
measure: Number of Participants with Adverse Events
time frame: 16 weeks
arm group label: Darbepoetin alfa
arm group type: Experimental
description: Participants received once a week darbepoetin alfa, administered by subcutaneous injection at a starting dose of 2.25 µg/kg for up to 12 weeks. The dose of darbepoetin alfa may have been adjusted based on hemoglobin levels to a maximum dose of 4.5 µg/kg /week.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received once a week placebo, administered by subcutaneous injection for up to 12 weeks.
intervention type: Drug
intervention name: Darbepoetin alfa
description: Administered by subcutaneous injection once a week
arm group label: Darbepoetin alfa
other name: Novel Erythropoiesis Stimulating Protein (NESP)
other name: Aranesp
intervention type: Drug
intervention name: Placebo
description: Placebo matching to darbopoetin alfa administered by subcutaneous injection once a week.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Anemia
mesh term: Darbepoetin alfa