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A Study of Darbepoetin Alfa for the 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 - 2.25 mcg/kg
Darbepoetin alfa - 500mcg
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, Darbepoetin alfa, Clinical Trial

Eligibility Criteria

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

Inclusion Criteria: Non-myeloid malignancy At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule Eastern Cooperative Oncology Group performance status of 0-2 Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization Of legal age at the time written informed consent is obtained Exclusion Criteria: Known history of seizure disorder Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy Unstable or uncontrolled disease/condition, related to or affecting cardiac function Clinically significant inflammatory disease Inadequate renal and/or liver function Known positive HIV test Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO Received more than 2 red blood cell (RBC) transfusions within 4 weeks before 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 before randomization or any planned erythropoietic therapy between randomization and study day 1 Other investigational procedures Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority Pregnant or breast feeding Not using adequate contraceptive precautions Known sensitivity to any of the products to be administered during dosing Previously randomized in this study Concerns for subject's compliance with protocol procedures

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Darbepoetin alfa 500 mcg - Group A

    Darbepoetin alfa 2.25 mcg/kg - Group B

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence of at least one 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 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP
    Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP
    Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP
    Change in FACT-G Physical Well-being subscale from baseline to EOTP
    Change in hemoglobin from baseline to EOTP
    Change in FACT-Fatigue subscale score from baseline to EOTP
    Change in FACT-G total score from baseline to EOTP
    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
    Incidence and severity of adverse events
    Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study
    Change in number of caregiver hours 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
    Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences
    Incidence of a confirmed antibody formation to darbepoetin alfa

    Full Information

    First Posted
    June 30, 2005
    Last Updated
    April 25, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00118638
    Brief Title
    A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
    Official Title
    A Randomized, Double Blind, Active-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
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2004 (undefined)
    Primary Completion Date
    December 2004 (Actual)
    Study Completion Date
    January 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

    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, Darbepoetin alfa, Clinical Trial

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Darbepoetin alfa 500 mcg - Group A
    Arm Type
    Experimental
    Arm Title
    Darbepoetin alfa 2.25 mcg/kg - Group B
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin alfa - 2.25 mcg/kg
    Intervention Description
    Darbepoetin alfa 2.25 mcg/kg QW dosing/ placebo Q3W
    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin alfa - 500mcg
    Intervention Description
    Darbepoetin alfa 500mcg Q3W dosing / placebo QW
    Primary Outcome Measure Information:
    Title
    Incidence of at least one 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 11.0 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
    Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP
    Time Frame
    from week 1 (day 1) to EOTP
    Title
    Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP
    Time Frame
    from week 1 to EOTP
    Title
    Change in FACT-G Physical Well-being subscale from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Change in hemoglobin from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Change in FACT-Fatigue subscale score from baseline to EOTP
    Time Frame
    from baseline to EOTP
    Title
    Change in FACT-G total score from baseline to EOTP
    Time Frame
    from baseline to EOTP
    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
    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 number of caregiver hours 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
    Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences
    Time Frame
    throughout study
    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: Non-myeloid malignancy At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule Eastern Cooperative Oncology Group performance status of 0-2 Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization Of legal age at the time written informed consent is obtained Exclusion Criteria: Known history of seizure disorder Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy Unstable or uncontrolled disease/condition, related to or affecting cardiac function Clinically significant inflammatory disease Inadequate renal and/or liver function Known positive HIV test Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO Received more than 2 red blood cell (RBC) transfusions within 4 weeks before 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 before randomization or any planned erythropoietic therapy between randomization and study day 1 Other investigational procedures Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority Pregnant or breast feeding Not using adequate contraceptive precautions Known sensitivity to any of the products to be administered during dosing Previously randomized in this study Concerns for subject's compliance with protocol procedures
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    Citation
    Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B,
    Results Reference
    background
    PubMed Identifier
    22081263
    Citation
    Canon JL, Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Legg J, Pujol B, Bridges K. Transfusion risk in cancer patients with chemotherapy-induced anemia when initiating darbepoetin alfa therapy at a baseline hemoglobin level of <9 g/dL versus 9 to <10 g/dL versus >/= 10 g/dL: an exploratory analysis of a phase 3 trial. Med Oncol. 2012 Sep;29(3):2291-9. doi: 10.1007/s12032-011-0103-x. Epub 2011 Nov 13.
    Results Reference
    result
    PubMed Identifier
    16478746
    Citation
    Canon JL, Vansteenkiste J, Bodoky G, Mateos MV, Bastit L, Ferreira I, Rossi G, Amado RG. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst. 2006 Feb 15;98(4):273-84. doi: 10.1093/jnci/djj053.
    Results Reference
    result
    PubMed Identifier
    19728887
    Citation
    Vansteenkiste J, Hedenus M, Gascon P, Bokemeyer C, Ludwig H, Vermorken J, Hamilton L, Bridges K, Pujol B. Darbepoetin alfa for treating chemotherapy-induced anemia in patients with a baseline hemoglobin level < 10 g/dL versus > or = 10 g/dL: an exploratory analysis from a randomized, double-blind, active-controlled trial. BMC Cancer. 2009 Sep 3;9:311. doi: 10.1186/1471-2407-9-311.
    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/20030231.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

    A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

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