A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer
Inclusion Criteria:
- subjects with non-myeloid malignancies
- anemia due to cancer
- ECOG status 0 to 2
- greater than or equal to 4-month expectancy
- greater than or equal to 18 years and of legal age for informed consent
- screening hemoglobin concentration less than or equal to 11.0g/dL
- adequate serum folate and vitamin B12
- adequate renal and liver function
- written informed consent
Exclusion Criteria:
- subjects currently receiving or planned to receive cytotoxic chemotherapy or
myelosuppressive radiotherapy during the study or within 4 weeks before randomization
- in complete remission, as determined by the investigator
- subjects who have other diagnoses not related to the cancer which cause anemia (eg.
gastrointestinal bleeding, renal disease, etc)
- documented history of pure red cell aplasia
- Known history of seizure disorder
- cardiac condition: uncontrolled angina, congestive heart failure, known ejection
fraction less than 40%, or uncontrolled cardiac arrhythmia
- uncontrolled hypertension
- clinically significant systemic infection or chronic inflammatory disease present at
the time of randomization
- iron deficiency
- known positive test for HIV infection
- previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or
darbepoetin alfa
- received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
- 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
- subject of reproductive potential who is not using adequate contraceptive precautions
- known hypersensitivity to mammalian-derived product or any other ingredients in the
investigational product
- previously randomized into this study
- concerns for subject's compliance with the protocol procedures