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Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: May 20, 2005
Last updated: May 6, 2013
Last verified: May 2013
The purpose of this study is to compare the effect of darbepoetin alfa administered in a weight based versus fixed dosing for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.

Condition Intervention Phase
Anemia Non-Myeloid Malignancies Cancer Drug: Darbepoetin alfa Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) Using Fixed and Weight-Based Dosing for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Achieving a hemoglobin concentration greater than or equal to 12.0 g/dL or a greater than or equal to 2.0-g/dL increase in hemoglobin concentration compared to baseline

Secondary Outcome Measures:
  • Time to and percentage of subjects with a hemoglobin response
  • Time to and percentage of subjects with hemoglobin correction
  • Hemoglobin concentration and change in hemoglobin concentration from baseline
  • Time to first RBC transfusion and percentage of subjects receiving a RBC transfusion


Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
Inclusion Criteria: - Planned chemotherapy treatment - Anemia (hemoglobin concentration less than or equal to 11.0 g/dL) - Adequate renal and liver function - Eastern Cooperative Oncology Group (ECOG) 0 to 2 - Subjects must provide written informed consent 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 - Known positive test for HIV infection - Transfusion within 4 weeks of randomization - Neutralizing antibodies to any erythropoietic agent - Treatment with erythropoietic therapy within 4 weeks before randomization - Received any investigational drug or device within 30 days before randomization - 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
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Please refer to this study by its identifier: NCT00111462

Sponsors and Collaborators
Study Director: MD Amgen
  More Information