Status:
TERMINATED
Darbepoetin Alfa and Anemia of Cancer
Lead Sponsor:
Amgen
Conditions:
Anemia
Anemia of Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (H...
Eligibility Criteria
Inclusion
- nonmyeloid malignancies (including lymphocytic leukemias)
- anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- adequate liver and renal functions
- 18 years or older
Exclusion
- history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening
- acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome
- known hematologic disorders that could cause anemia
- inflammatory or cardiac disorders
- previous positive antibody response to any erythropoietic agent
- history of pure red cell aplasia
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2004
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT00989092
Start Date
May 1 2002
End Date
June 1 2004
Last Update
January 29 2014
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