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A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Darbepoetin alfa
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lung cancer (either small cell [SCLC] or non-small cell [NSCLC])
  • At least 12 additional weeks of platinum containing cyclic chemotherapy planned regardless of cycle length
  • Anemia (hemoglobin ≤ 11.0 g/dL) as assessed by a local or central laboratory result within 7 days before study day 1 (the first scheduled day of on-study chemotherapy and the first day of study drug administration)
  • Life expectancy of at least 6 months, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Anemia predominantly due to the cancer or chemotherapy (i.e.. serum folate ≥ 4.5 nmol/L (≥ 2.0 ng/mL) and vitamin B 12 ≥ 148 pmol/L (≥ 200 pg/mL), no overt hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery)
  • Adequate renal function (creatinine ≤ 177gmol/L (≤ 2.0 mg/dL) and adequate hepatic function (bilirubin ≤ 1.5 times central laboratory's upper limit of normal range)
  • Available for 4 weeks post administration of the last dose of study drug
  • Legal age for informed consent, and written informed consent must be obtained

Exclusion Criteria:

  • History of any primary hematological disorder which could cause anemia (e.g., sickle cell anemia)
  • Received prior whole pelvis radiation therapy
  • Uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%)], or uncontrolled cardiac arrhythmia.
  • History of primary or metastatic malignancy involving the central nervous system (CNS). Subjects with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study providing they have had no clinical signs of nor treatment for CNS disease and no history of seizures within previous 2 years
  • Uncontrolled hypertension (i.e., diastolic blood pressure > 100 mm Hg)
  • History of seizures. Subjects with a previous history of seizures will be eligible for the study providing they have had no evidence of seizure activity and have been free of anti-seizure medication for the previous 5 years
  • Evidence of clinically significant systemic active infection or chronic inflammatory disease (e.g., rheumatoid arthritis)
  • Iron deficiency (transferrin saturation < 15% and ferritin < 10 μg/L (< 10 ng/mL))
  • Received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
  • Received erythropoietin therapy within 8 weeks before randomization
  • Known positive test for human immunodeficiency virus (HIV) infection
  • Receiving, or not yet 30 days past the end of receiving, another investigational agent or device not approved in any indication.
  • Pregnant or breast feeding females.
  • Not using adequate contraceptive precautions
  • Prior treatment with NESP
  • Previously randomized in this study
  • Known hypersensitivity to mammalian-derived product
  • Concerns for subject's compliance with the protocol procedure, including completion of the quality of life surveys (QOLS)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Darbepoetin alfa

    Placebo

    Arm 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.

    Participants received once a week placebo, administered by subcutaneous injection for up to 12 weeks.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12

    Secondary Outcome Measures

    Time to First Red Blood Cell Transfusion During Weeks 5 to 12
    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.
    Percentage of Participants with a Hemoglobin Response by Week 12
    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.
    Time to Hemoglobin Response
    The number of days from the first administration of study drug to the first occurrence of a hemoglobin response.
    Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12
    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.
    Time to Sustained Hemoglobin Response
    The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin response.
    Percentage of Participants who Achieved a Hemoglobin Correction by Week 12
    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.
    Percentage of Participants who Achieved a Sustained Hemoglobin Correction by Week 12
    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.
    Time to Hemoglobin Correction
    The number of days from the first administration of study drug to the first occurrence of a hemoglobin correction.
    Time to Sustained Hemoglobin Correction
    The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin correction.
    Change from Baseline in Hemoglobin at Week 12
    Percentage of Participants who Received a Red Blood Cell Transfusion During Weeks 1 to 4, 5 to 8, and 9 to 12
    Number of Standard Units of RBCs Transfused During Weeks 5 to 12
    Number of Days with RBC Transfusions During Weeks 5 to 12
    Change from Baseline in the Functional Assessment of Cancer Therapy (FACT)-Anemia Subscales at Week 12
    The FACT-anemia is a 47-item questionnaire to assess specific quality of life concerns related to anemia and fatigue in cancer patients.
    Number of Participants with Adverse Events

    Full Information

    First Posted
    December 13, 2018
    Last Updated
    December 18, 2018
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03776032
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 14, 1999 (Actual)
    Primary Completion Date
    November 8, 2000 (Actual)
    Study Completion Date
    February 27, 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia
    Keywords
    Lung cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    320 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Darbepoetin alfa
    Arm Type
    Experimental
    Arm 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 Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants received once a week placebo, administered by subcutaneous injection for up to 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin alfa
    Other Intervention Name(s)
    Novel Erythropoiesis Stimulating Protein (NESP), Aranesp
    Intervention Description
    Administered by subcutaneous injection once a week
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo matching to darbopoetin alfa administered by subcutaneous injection once a week.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12
    Time Frame
    Weeks 5 to 12
    Secondary Outcome Measure Information:
    Title
    Time to First Red Blood Cell Transfusion During Weeks 5 to 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.
    Time Frame
    Week 5 to week 12
    Title
    Percentage of Participants with a Hemoglobin Response by Week 12
    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.
    Time Frame
    12 weeks
    Title
    Time to Hemoglobin Response
    Description
    The number of days from the first administration of study drug to the first occurrence of a hemoglobin response.
    Time Frame
    12 weeks
    Title
    Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12
    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.
    Time Frame
    12 weeks
    Title
    Time to Sustained Hemoglobin Response
    Description
    The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin response.
    Time Frame
    12 weeks
    Title
    Percentage of Participants who Achieved a Hemoglobin Correction by Week 12
    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.
    Time Frame
    12 weeks
    Title
    Percentage of Participants who Achieved a Sustained Hemoglobin Correction by Week 12
    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.
    Time Frame
    12 weeks
    Title
    Time to Hemoglobin Correction
    Description
    The number of days from the first administration of study drug to the first occurrence of a hemoglobin correction.
    Time Frame
    12 weeks
    Title
    Time to Sustained Hemoglobin Correction
    Description
    The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin correction.
    Time Frame
    12 weeks
    Title
    Change from Baseline in Hemoglobin at Week 12
    Time Frame
    Baseline and week 12
    Title
    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
    Title
    Number of Standard Units of RBCs Transfused During Weeks 5 to 12
    Time Frame
    Weeks 5 to 12
    Title
    Number of Days with RBC Transfusions During Weeks 5 to 12
    Time Frame
    Weeks 5 to 12
    Title
    Change from Baseline in the Functional Assessment of Cancer Therapy (FACT)-Anemia Subscales at 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.
    Time Frame
    Baseline and week 12
    Title
    Number of Participants with Adverse Events
    Time Frame
    16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Lung cancer (either small cell [SCLC] or non-small cell [NSCLC]) At least 12 additional weeks of platinum containing cyclic chemotherapy planned regardless of cycle length Anemia (hemoglobin ≤ 11.0 g/dL) as assessed by a local or central laboratory result within 7 days before study day 1 (the first scheduled day of on-study chemotherapy and the first day of study drug administration) Life expectancy of at least 6 months, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Anemia predominantly due to the cancer or chemotherapy (i.e.. serum folate ≥ 4.5 nmol/L (≥ 2.0 ng/mL) and vitamin B 12 ≥ 148 pmol/L (≥ 200 pg/mL), no overt hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery) Adequate renal function (creatinine ≤ 177gmol/L (≤ 2.0 mg/dL) and adequate hepatic function (bilirubin ≤ 1.5 times central laboratory's upper limit of normal range) Available for 4 weeks post administration of the last dose of study drug Legal age for informed consent, and written informed consent must be obtained Exclusion Criteria: History of any primary hematological disorder which could cause anemia (e.g., sickle cell anemia) Received prior whole pelvis radiation therapy Uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%)], or uncontrolled cardiac arrhythmia. History of primary or metastatic malignancy involving the central nervous system (CNS). Subjects with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study providing they have had no clinical signs of nor treatment for CNS disease and no history of seizures within previous 2 years Uncontrolled hypertension (i.e., diastolic blood pressure > 100 mm Hg) History of seizures. Subjects with a previous history of seizures will be eligible for the study providing they have had no evidence of seizure activity and have been free of anti-seizure medication for the previous 5 years Evidence of clinically significant systemic active infection or chronic inflammatory disease (e.g., rheumatoid arthritis) Iron deficiency (transferrin saturation < 15% and ferritin < 10 μg/L (< 10 ng/mL)) Received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization Received erythropoietin therapy within 8 weeks before randomization Known positive test for human immunodeficiency virus (HIV) infection Receiving, or not yet 30 days past the end of receiving, another investigational agent or device not approved in any indication. Pregnant or breast feeding females. Not using adequate contraceptive precautions Prior treatment with NESP Previously randomized in this study Known hypersensitivity to mammalian-derived product Concerns for subject's compliance with the protocol procedure, including completion of the quality of life surveys (QOLS)

    12. IPD Sharing Statement

    Learn more about this trial

    A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy

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