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Darbepoetin Alfa With or Without Intravenous (IV) Iron

Primary Purpose

Anemia, Non-Myeloid Malignancies

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
darbepoetin alfa
IV iron dextran
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring anemia, chemotherapy induced anemia, darbepoetin alfa, cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Active non myeloid malignancy(cies) including lymphocytic leukemias
  • Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy
  • Anemia due to chemotherapy (screening Hgb <or = 10.0 g/dL)
  • at least 18 years of age at screening

Exclusion Criteria:

  • Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS)
  • Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy
  • Active bleeding
  • Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis)
  • Active, unstable systemic or chronic infection
  • Planned elective surgery during the study where significant blood loss is expected
  • Unstable angina, or uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension (diastolic blood pressure > 100 mmHg)
  • History of pure red cell aplasia (PRCA)
  • History of deep venous thrombosis
  • Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status
  • Any red-blood-cell (RBC) transfusion within 28 days before randomization and/or during screening
  • Currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy
  • Currently receiving or planned to receive myeloablative radiation therapy
  • Received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study
  • Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa)
  • Known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study
  • Known sensitivity to iron administration
  • Pregnant or breast feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Darbepoetin alfa 300 μg plus IV Iron

    Darbepoetin alfa 300 μg

    Darbepoetin alfa 500 μg

    Darbepoetin alfa 500 μg plus IV Iron

    Arm Description

    Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

    Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

    Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

    Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).

    Outcomes

    Primary Outcome Measures

    Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose
    Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
    Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage
    Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.

    Secondary Outcome Measures

    Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose
    The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
    Time to Achieve the Target Hemoglobin Level, by IV Iron Usage
    The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
    Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose
    Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
    Change From Baseline in Hemoglobin Concentration, by IV Iron Usage
    Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
    Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose
    The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
    Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage
    The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
    Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study
    Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
    Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose
    Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.
    Number of Participants With a Hematopoietic Response, by IV Iron Usage
    Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.
    Time to Hematopoietic Response, by Darbepoetin Alfa Dose
    The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
    Time to Hematopoietic Response, by IV Iron Usage
    The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
    Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose
    Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.
    Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage
    Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.

    Full Information

    First Posted
    November 16, 2006
    Last Updated
    December 10, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00401544
    Brief Title
    Darbepoetin Alfa With or Without Intravenous (IV) Iron
    Official Title
    Once Per Cycle Treatment of Anemia With Darbepoetin Alfa With Iron in Subjects With Non Myeloid Malignancies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients with non-myeloid malignancies who were receiving multicycle chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Non-Myeloid Malignancies
    Keywords
    anemia, chemotherapy induced anemia, darbepoetin alfa, cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    243 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Darbepoetin alfa 300 μg plus IV Iron
    Arm Type
    Experimental
    Arm Description
    Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
    Arm Title
    Darbepoetin alfa 300 μg
    Arm Type
    Experimental
    Arm Description
    Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
    Arm Title
    Darbepoetin alfa 500 μg
    Arm Type
    Experimental
    Arm Description
    Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
    Arm Title
    Darbepoetin alfa 500 μg plus IV Iron
    Arm Type
    Active Comparator
    Arm Description
    Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
    Intervention Type
    Drug
    Intervention Name(s)
    darbepoetin alfa
    Other Intervention Name(s)
    Aranesp®
    Intervention Description
    Darbepoetin alfa administered by subcutaneous injection.
    Intervention Type
    Drug
    Intervention Name(s)
    IV iron dextran
    Other Intervention Name(s)
    INFeD®, Cosmofer®
    Intervention Description
    Administered by intravenous (IV) injection.
    Primary Outcome Measure Information:
    Title
    Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose
    Description
    Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
    Time Frame
    From Week 1 to Week 16
    Title
    Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage
    Description
    Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.
    Time Frame
    From Week 1 to Week 16
    Secondary Outcome Measure Information:
    Title
    Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose
    Description
    The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
    Time Frame
    From Week 1 to Week 16
    Title
    Time to Achieve the Target Hemoglobin Level, by IV Iron Usage
    Description
    The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.
    Time Frame
    From Week 1 to Week 16
    Title
    Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose
    Description
    Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
    Time Frame
    Baseline and Week 16
    Title
    Change From Baseline in Hemoglobin Concentration, by IV Iron Usage
    Description
    Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).
    Time Frame
    Baseline and Week 16
    Title
    Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose
    Description
    The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
    Time Frame
    From Week 1 to Week 16
    Title
    Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage
    Description
    The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
    Time Frame
    From Week 1 to Week 16
    Title
    Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study
    Description
    Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.
    Time Frame
    From Week 5 to Week 16
    Title
    Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose
    Description
    Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.
    Time Frame
    From Week 1 to Week 16
    Title
    Number of Participants With a Hematopoietic Response, by IV Iron Usage
    Description
    Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.
    Time Frame
    From Week 1 to Week 16
    Title
    Time to Hematopoietic Response, by Darbepoetin Alfa Dose
    Description
    The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
    Time Frame
    From Week 1 to Week 16
    Title
    Time to Hematopoietic Response, by IV Iron Usage
    Description
    The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.
    Time Frame
    From Week 1 to Week 16
    Title
    Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose
    Description
    Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.
    Time Frame
    Baseline and Week 16
    Title
    Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage
    Description
    Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.
    Time Frame
    Baseline and Week 16

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Active non myeloid malignancy(cies) including lymphocytic leukemias Received chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy Anemia due to chemotherapy (screening Hgb <or = 10.0 g/dL) at least 18 years of age at screening Exclusion Criteria: Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) Other underlying hematologic disorder, which could cause anemia, other than a non myeloid malignancy Active bleeding Severe, unstable, active chronic inflammatory disease (eg ulcerative disease, peptic ulcer disease, rheumatoid arthritis) Active, unstable systemic or chronic infection Planned elective surgery during the study where significant blood loss is expected Unstable angina, or uncontrolled cardiac arrhythmia Uncontrolled hypertension (diastolic blood pressure > 100 mmHg) History of pure red cell aplasia (PRCA) History of deep venous thrombosis Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status Any red-blood-cell (RBC) transfusion within 28 days before randomization and/or during screening Currently receiving thalidomide or lenalidomide without prophylactic anticoagulant therapy Currently receiving or planned to receive myeloablative radiation therapy Received bone marrow or stem cell transplant in the 6 months prior to screening or planned during the study Received any erythropoietic therapy within 28 days before randomization and/or during screening (eg rHuEPO or darbepoetin alfa) Known sensitivity to any erythropoietic agents, the investigational product or its excipients to be administered during this study Known sensitivity to iron administration Pregnant or breast feeding
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20661916
    Citation
    Auerbach M, Silberstein PT, Webb RT, Averyanova S, Ciuleanu TE, Shao J, Bridges K. Darbepoetin alfa 300 or 500 mug once every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Am J Hematol. 2010 Sep;85(9):655-63. doi: 10.1002/ajh.21779.
    Results Reference
    result
    Links:
    URL
    http://www.aranesp.com/
    Description
    FDA-approved Drug Labeling
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    Darbepoetin Alfa With or Without Intravenous (IV) Iron

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