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Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

Primary Purpose

Anemia, Non-Myeloid Malignancies

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 Non-myeloid malignancy, Chemotherapy-induced anemia

Eligibility Criteria

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

Inclusion Criteria: Subjects with non-myeloid malignancy At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization Adequate serum folate and vitamin B12 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Of legal age at the time written informed consent is obtained Exclusion Criteria: Known history of seizure disorder Known primary hematologic disorder causing anemia other than non-myeloid malignancies Unstable/uncontrolled cardiac condition Clinically significant inflammatory disease Other diagnoses not related to the cancer which can cause anemia Inadequate renal and liver function Iron deficiency Known positive test for HIV infection Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1 Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1 Other investigational procedures Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s) Pregnant or breast feeding Not using adequate contraceptive precautions Previously randomized into this study Known hypersensitivity to any products to be administered Concerns for subject's compliance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Darbepoetin alfa - Group A

    Placebo- Group B

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)

    Secondary Outcome Measures

    Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP
    Number of RBC transfusions from week 5 to EOTP
    Change in FACT-Fatigue subscale score from baseline to EOTP
    Change in FACT-G Physical Well-being subscale from baseline to EOTP
    Incidence and severity of adverse events
    Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study
    Change in FACT-G total score from baseline to EOTP
    Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences
    Change in EQ-5D Thermometer from baseline to EOTP
    Change in BSI Anxiety scale score from baseline to EOTP
    Change in BSI Depression scale score from baseline to EOTP
    Change in number of caregiver hours from baseline to EOTP
    Incidence of a confirmed antibody formation to darbepoetin alfa

    Full Information

    First Posted
    May 16, 2005
    Last Updated
    January 14, 2010
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00110955
    Brief Title
    Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2004 (undefined)
    Primary Completion Date
    March 2005 (Actual)
    Study Completion Date
    April 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies 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
    Non-myeloid malignancy, Chemotherapy-induced anemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    391 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Darbepoetin alfa - Group A
    Arm Type
    Experimental
    Arm Title
    Placebo- Group B
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin alfa
    Intervention Description
    Q3W 300 mcg darbepoetin alfa
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Q3W dosing of placebo
    Primary Outcome Measure Information:
    Title
    Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
    Time Frame
    from week 5 to EOTP
    Secondary Outcome Measure Information:
    Title
    Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP
    Time Frame
    from week 5 to EOTP
    Title
    Number of RBC transfusions from week 5 to EOTP
    Time Frame
    from week 5 to EOTP
    Title
    Change in FACT-Fatigue subscale score from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Change in FACT-G Physical Well-being subscale from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Incidence and severity of adverse events
    Time Frame
    throughout study
    Title
    Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study
    Time Frame
    at any time on study
    Title
    Change in FACT-G total score from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences
    Time Frame
    throughout study
    Title
    Change in EQ-5D Thermometer from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Change in BSI Anxiety scale score from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Change in BSI Depression scale score from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Change in number of caregiver hours from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Incidence of a confirmed 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: Subjects with non-myeloid malignancy At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization Adequate serum folate and vitamin B12 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Of legal age at the time written informed consent is obtained Exclusion Criteria: Known history of seizure disorder Known primary hematologic disorder causing anemia other than non-myeloid malignancies Unstable/uncontrolled cardiac condition Clinically significant inflammatory disease Other diagnoses not related to the cancer which can cause anemia Inadequate renal and liver function Iron deficiency Known positive test for HIV infection Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1 Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1 Other investigational procedures Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s) Pregnant or breast feeding Not using adequate contraceptive precautions Previously randomized into this study Known hypersensitivity to any products to be administered Concerns for subject's compliance
    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
    19601709
    Citation
    Hernandez E, Ganly P, Charu V, Dibenedetto J, Tomita D, Lillie T, Taylor K; ARANESP 20030232 Study Group. Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia. Curr Med Res Opin. 2009 Sep;25(9):2109-20. doi: 10.1185/03007990903084164.
    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/20030232_Posting_Summ_NESP.pdf
    Description
    To access clinical trial results information click on this link
    URL
    http://www.aranesp.com/
    Description
    FDA-approved Drug Labeling

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    Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

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