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