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Flexibility: A Study to Assess the Impact of Darbepoetin Alfa in Subjects withNon-Myeloid Malignancies With Anemia Due to Chemotherapy

Primary Purpose

Anemia, Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Aranesp®
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Chemotherapy, Anemia, Aranesp®, rHuEPO, Chemotherapy Induced Anemia, non-myeloid malignancy, Non-Myeloid Malignancies, Chemotherapy

Eligibility Criteria

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

Inclusion Criteria: - Subjects with active non-myeloid malignancy(ies) including lymphocytic leukemias - Receiving chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy anticipated to be on a QW, every other week (Q2W) or every three weeks (Q3W) schedule - Anemia due to cancer and/or chemotherapy (screening Hb less than 11.0 g/dL) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: - Subjects with 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 (e.g., 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 - Known iron deficiency (to be considered iron deficient a subject must have both of the following: a saturated transferrin less than 15% and ferritin less than 10 ng/mL at screening) - Unstable angina, or uncontrolled cardiac arrhythmia - Hypertension (diastolic blood pressure greater than 100 mmHg) - Inadequate renal and/or liver function (e.g., creatinine greater than 2 X upper limit of normal (ULN) and/or transaminase greater than 5 X ULN) - History of pure red blood cell aplasia - Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status - Known positive antibody response to any erythropoietic agent - Subject has known sensitivity to any erythropoietic agents, the study drug, or its excipients to be administered during this study

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Change in hemoglobin (Hb) in chemotherapy induced anemia

    Secondary Outcome Measures

    Patient-reported outcomes including overall health, fatigue, and daily activities

    Full Information

    First Posted
    September 1, 2005
    Last Updated
    May 22, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00144131
    Brief Title
    Flexibility: A Study to Assess the Impact of Darbepoetin Alfa in Subjects withNon-Myeloid Malignancies With Anemia Due to Chemotherapy
    Official Title
    Flexibility: A Study to Assess the Impact of Once Per Cycle Correction and Maintenance Dosing of Darbepoetin Alfa in Subjects With Non-Myeloid Malignancies With Anemia Due to Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2005 (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
    This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®) extended dose schedule administration (EDS) versus darbepoetin alfa administered once per week (QW) in the treatment of anemia in subjects with non-myeloid malignancies receiving multi-cycle chemotherapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Cancer
    Keywords
    Chemotherapy, Anemia, Aranesp®, rHuEPO, Chemotherapy Induced Anemia, non-myeloid malignancy, Non-Myeloid Malignancies, Chemotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    750 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Aranesp®
    Primary Outcome Measure Information:
    Title
    Change in hemoglobin (Hb) in chemotherapy induced anemia
    Secondary Outcome Measure Information:
    Title
    Patient-reported outcomes including overall health, fatigue, and daily activities

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Subjects with active non-myeloid malignancy(ies) including lymphocytic leukemias - Receiving chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy anticipated to be on a QW, every other week (Q2W) or every three weeks (Q3W) schedule - Anemia due to cancer and/or chemotherapy (screening Hb less than 11.0 g/dL) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: - Subjects with 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 (e.g., 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 - Known iron deficiency (to be considered iron deficient a subject must have both of the following: a saturated transferrin less than 15% and ferritin less than 10 ng/mL at screening) - Unstable angina, or uncontrolled cardiac arrhythmia - Hypertension (diastolic blood pressure greater than 100 mmHg) - Inadequate renal and/or liver function (e.g., creatinine greater than 2 X upper limit of normal (ULN) and/or transaminase greater than 5 X ULN) - History of pure red blood cell aplasia - Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status - Known positive antibody response to any erythropoietic agent - Subject has known sensitivity to any erythropoietic agents, the study drug, or its excipients to be administered during this study
    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
    20973982
    Citation
    Schwartzberg L, Burkes R, Mirtsching B, Rearden T, Silberstein P, Yee L, Inamoto A, Lillie T. Comparison of darbepoetin alfa dosed weekly (QW) vs. extended dosing schedule (EDS) in the treatment of anemia in patients receiving multicycle chemotherapy in a randomized, phase 2, open-label trial. BMC Cancer. 2010 Oct 25;10:581. doi: 10.1186/1471-2407-10-581.
    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_20040262.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

    Flexibility: A Study to Assess the Impact of Darbepoetin Alfa in Subjects withNon-Myeloid Malignancies With Anemia Due to Chemotherapy

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