Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

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

Inclusion Criteria:

• Subjects with non-myeloid malignancy
• At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
• Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization
• Adequate serum folate and vitamin B12
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Of legal age at the time written informed consent is obtained

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
• Other diagnoses not related to the cancer which can cause anemia
• Inadequate renal and liver function
• Iron deficiency
• Known positive test for HIV infection
• Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
• Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1
• Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1
• Other investigational procedures
• Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s)
• 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