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