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
Phase 2
N/A
N/A
N/A
N/A
Not Enrolling
Both
Anemia, Non-Myeloid Malignancies, Cancer
Both
Anemia, Non-Myeloid Malignancies, Cancer
Trial Information
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
Inclusion Criteria:
- Planned chemotherapy treatment - Anemia (hemoglobin concentrationless 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20010102
NCT ID:
NCT00111462
Start Date:
Completion Date:
Related Keywords:
- Anemia
- Non-Myeloid Malignancies
- Cancer
- non-myeloid malignancy
- chemotherapy-induced anemia
- Anemia
- Neoplasms
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