A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Anemia, Non-Myeloid Malignancies
Both
Anemia, Non-Myeloid Malignancies
Trial Information
A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy
Inclusion Criteria:
- Diagnosed with a non-myeloid malignancy
- Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the
time of first dose of study drug
- Screening hemoglobin concentration less than or equal to 11.0g/dL
- ECOG performance status of 0 to 2
- Adequate renal and liver function
Exclusion Criteria:
- History of seizure disorder
- Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within
4 weeks before study day 1
- More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red
blood cell transfusion within 14 days before study day 1
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
Outcome Time Frame:
from baseline to the end of treatment period (EOTP)
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20010199
NCT ID:
NCT00035607
Start Date:
December 2001
Completion Date:
April 2003
Related Keywords:
- Anemia
- Non-Myeloid Malignancies
- Anemia
- Neoplasms
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