Study for the Treatment of Anemia in Patients With Non-myeloid Malignancies Receiving Multicycle Chemotherapy.
Status and phase
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Details and patient eligibility
About
Comparing two drugs to treat subjects with non-myeloid malignancies receiving multicycle chemotherapy.
Full description
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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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