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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00111462 |
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 |
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Anemia Non-Myeloid Malignancies Cancer |
Drug: Darbepoetin alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Factorial Assignment |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010102 |
Study First Received: | May 20, 2005 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00111462 |
Health Authority: | United States: Food and Drug Administration |
non-myeloid malignancy chemotherapy-induced anemia |
Body Weight Hematologic Diseases Darbepoetin alfa Anemia |
Neoplasms Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |