A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy

A Randomized, Double Blind, Active-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 evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.

Inclusion Criteria:

• Non-myeloid malignancy
• At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
• Eastern Cooperative Oncology Group performance status of 0-2
• Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
• Of legal age at the time written informed consent is obtained

Exclusion Criteria:

• Known history of seizure disorder
• Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
• Unstable or uncontrolled disease/condition, related to or affecting cardiac function
• Clinically significant inflammatory disease
• Inadequate renal and/or liver function
• Known positive HIV test
• Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
• Received more than 2 red blood cell (RBC) transfusions within 4 weeks before 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 before randomization or any planned erythropoietic therapy between randomization and study day 1
• Other investigational procedures
• Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
• Pregnant or breast feeding
• Not using adequate contraceptive precautions
• Known sensitivity to any of the products to be administered during dosing
• Previously randomized in this study
• Concerns for subject's compliance with protocol procedures