Flexibility: A Study to Assess the Impact of Once Per Cycle Correction and Maintenance Dosing of Darbepoetin Alfa in Subjects With Non-Myeloid Malignancies With Anemia Due to Chemotherapy
Inclusion Criteria:
- Subjects with active non-myeloid malignancy(ies) including
lymphocytic leukemias - Receiving chemotherapy and expected to receive at least 8
additional weeks of cyclic cytotoxic chemotherapy anticipated to be on a QW, every other
week (Q2W) or every three weeks (Q3W) schedule - Anemia due to cancer and/or chemotherapy
(screening Hb less than 11.0 g/dL) - Eastern Cooperative Oncology Group (ECOG) performance
status of 0 to 2 Exclusion Criteria: - Subjects with acute myelogenous leukemia (AML),
chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) - Other underlying
hematologic disorder, which could cause anemia, other than a non-myeloid malignancy -
Active bleeding - Severe, unstable, active chronic inflammatory disease (e.g., ulcerative
disease, peptic ulcer disease, rheumatoid arthritis) - Active, unstable systemic or
chronic infection - Planned elective surgery during the study where significant blood loss
is expected - Known iron deficiency (to be considered iron deficient a subject must have
both of the following: a saturated transferrin less than 15% and ferritin less than 10
ng/mL at screening) - Unstable angina, or uncontrolled cardiac arrhythmia - Hypertension
(diastolic blood pressure greater than 100 mmHg) - Inadequate renal and/or liver function
(e.g., creatinine greater than 2 X upper limit of normal (ULN) and/or transaminase greater
than 5 X ULN) - History of pure red blood cell aplasia - Known positive human
immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status -
Known positive antibody response to any erythropoietic agent - Subject has known
sensitivity to any erythropoietic agents, the study drug, or its excipients to be
administered during this study