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A Study of Darbepoetin Alfa Administered Once Every 2 Weeks (Q2W) Compared With Epoetin Alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.


Phase 3
18 Years
N/A
Not Enrolling
Both
Anemia

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Trial Information

A Study of Darbepoetin Alfa Administered Once Every 2 Weeks (Q2W) Compared With Epoetin Alfa Administered Once Every Week (QW) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.


The purpose of this study is to compare the effect of darbepoetin alfa and Epoetin alfa for
the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle
chemotherapy.


Inclusion Criteria:

- Planned chemotherapy treatment - Anemia (hemoglobin concentration
less than or equal to 11.0 g/dL) - Adequate renal and liver function - 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 - Neutralizing antibodies to rHuEPO - Epoetin alfa
or darbepoetin alfa 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 recombinant mammalian-derived product - Concerns for
subject's compliance

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduced incidence of transfusions

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Institutional Review Board

Study ID:

20030125

NCT ID:

NCT00148421

Start Date:

Completion Date:

Related Keywords:

  • Anemia
  • Non-myeloid malignancy
  • Chemotherapy-induced anemia
  • Anemia
  • Neoplasms

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