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

About this trial
This is an interventional treatment trial for Anemia focused on measuring Non-myeloid malignancy, Chemotherapy-induced anemia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Darbepoetin alfa - Group A
Placebo- Group B