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Chemotherapy Related Anemia

Primary Purpose

Anemia, Non-Myeloid Malignancies

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

About this trial

This is an interventional supportive care trial for Anemia

Eligibility Criteria

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

Inclusion Criteria: Diagnosed with a non-myeloid malignancy Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug Screening hemoglobin concentration less than or equal to 11.0g/dL ECOG performance status of 0 to 2 Adequate renal and liver function Exclusion Criteria: History of seizure disorder Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1 More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Darbepoetin alfa SC

    Darbepoetin alfa IV

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)

    Secondary Outcome Measures

    Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration
    Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP
    Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period
    Time to and percentage of subjects with a hemoglobin response during the treatment period
    Percentage of subjects who exceed the hemoglobin threshold
    Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events
    Incidence, if any, of neutralizing antibody formation to darbepoetin alfa

    Full Information

    First Posted
    May 3, 2002
    Last Updated
    May 9, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00035607
    Brief Title
    Chemotherapy Related Anemia
    Official Title
    A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    December 2002 (Actual)
    Study Completion Date
    April 2003 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Non-Myeloid Malignancies

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Darbepoetin alfa SC
    Arm Type
    Active Comparator
    Arm Title
    Darbepoetin alfa IV
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin alfa SC
    Intervention Description
    Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin alfa IV
    Intervention Description
    Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W
    Primary Outcome Measure Information:
    Title
    Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
    Time Frame
    from baseline to the end of treatment period (EOTP)
    Secondary Outcome Measure Information:
    Title
    Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration
    Time Frame
    throughout study
    Title
    Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP
    Time Frame
    from baseline to week 7 and from week 7 to EOTP
    Title
    Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period
    Time Frame
    during the treatment period
    Title
    Time to and percentage of subjects with a hemoglobin response during the treatment period
    Time Frame
    during the treatment period
    Title
    Percentage of subjects who exceed the hemoglobin threshold
    Time Frame
    throughout study
    Title
    Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events
    Time Frame
    throughout study
    Title
    Incidence, if any, of neutralizing antibody formation to darbepoetin alfa
    Time Frame
    throughout study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with a non-myeloid malignancy Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug Screening hemoglobin concentration less than or equal to 11.0g/dL ECOG performance status of 0 to 2 Adequate renal and liver function Exclusion Criteria: History of seizure disorder Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1 More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1
    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
    15860486
    Citation
    Justice G, Kessler JF, Jadeja J, Campos L, Weick J, Chen CF, Heatherington AC, Amado RG. A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia. Ann Oncol. 2005 Jul;16(7):1192-8. doi: 10.1093/annonc/mdi218. Epub 2005 Apr 28.
    Results Reference
    result
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_20010199.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.aranesp.com/
    Description
    FDA-approved Drug Labeling

    Learn more about this trial

    Chemotherapy Related Anemia

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