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Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy

Primary Purpose

Anemia, Non-Myeloid Malignancies, Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Darbepoetin alfa
Sponsored by
Amgen
About
Eligibility
Locations
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

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Eastern Cooperative Oncology Group (ECOG) 0 to 2 - Subjects must provide written informed consent 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 - Known positive test for HIV infection - Transfusion within 4 weeks of randomization - Neutralizing antibodies to any erythropoietic agent - Treatment with erythropoietic therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - 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

    Outcomes

    Primary Outcome Measures

    Achieving a hemoglobin concentration greater than or equal to 12.0 g/dL or a greater than or equal to 2.0-g/dL increase in hemoglobin concentration compared to baseline

    Secondary Outcome Measures

    Time to and percentage of subjects with a hemoglobin response
    Time to and percentage of subjects with hemoglobin correction
    Hemoglobin concentration and change in hemoglobin concentration from baseline
    Time to first RBC transfusion and percentage of subjects receiving a RBC transfusion

    Full Information

    First Posted
    May 20, 2005
    Last Updated
    May 6, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00111462
    Brief Title
    Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy
    Official Title
    A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) Using Fixed and Weight-Based Dosing 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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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 compare the effect of darbepoetin alfa administered in a weight based versus fixed dosing 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, Cancer
    Keywords
    non-myeloid malignancy, chemotherapy-induced anemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Darbepoetin alfa
    Primary Outcome Measure Information:
    Title
    Achieving a hemoglobin concentration greater than or equal to 12.0 g/dL or a greater than or equal to 2.0-g/dL increase in hemoglobin concentration compared to baseline
    Secondary Outcome Measure Information:
    Title
    Time to and percentage of subjects with a hemoglobin response
    Title
    Time to and percentage of subjects with hemoglobin correction
    Title
    Hemoglobin concentration and change in hemoglobin concentration from baseline
    Title
    Time to first RBC transfusion and percentage of subjects receiving a RBC transfusion

    10. Eligibility

    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Eastern Cooperative Oncology Group (ECOG) 0 to 2 - Subjects must provide written informed consent 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 - Known positive test for HIV infection - Transfusion within 4 weeks of randomization - Neutralizing antibodies to any erythropoietic agent - Treatment with erythropoietic therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - 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
    14770445
    Citation
    Hesketh PJ, Arena F, Patel D, Austin M, D'Avirro P, Rossi G, Colowick A, Schwartzberg L, Bertoli LF, Cole JT, Demetri G, Dessypris E, Dobbs T, Eisenberg P, Fleischman R, Hall J, Hoffman PC, Laber DA, Leonard J, Lester EP, McCachren S, McMeekin S, Meza L, Miller DS, Nand S, Oliff I, Paroly W, Pawl L, Perez A, Raftopoulos H, Rigas J, Rowland K, Scullin DC Jr, Tezcan H, Waples J, Ward J, Yee LK. A randomized controlled trial of darbepoetin alfa administered as a fixed or weight-based dose using a front-loading schedule in patients with anemia who have nonmyeloid malignancies. Cancer. 2004 Feb 15;100(4):859-68. doi: 10.1002/cncr.11954.
    Results Reference
    result
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy

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