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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00239239 |
The purpose of this study is to characterize the pharmacokinetics/pharmacodynamics (PK/PD) of darbepoetin alfa administered at a subcutaneous (SC) dose of 0.45 mcg/kg three times weekly (TIW) in anemic patients with non-myeloid malignancies receiving multicycle chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Non-Myeloid Malignancies Anemia Cancer |
Drug: Darbepoetin alfa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | An Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Darbepoetin Alfa Administered Three Times Per Week for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy |
Estimated Enrollment: | 44 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | June 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Non-myeloid malignancy - Currently receiving 3-week cyclic chemotherapy treatment with a minimum of 2 additional cycles of chemotherapy planned at the time of enrollment - Anemia predominately due to cancer or chemotherapy (Hb >= 9.0 and < 11.0 g/dL) at the time of screening - 18 years of age or older at the time of screening - Eastern Cooperative Oncology Group (ECOG) score 0-2 - Adequate liver and kidney function Exclusion Criteria: - Known primary hematologic disorder, which could cause anemia, other than non-myeloid malignancies - History of chronic myeloid leukemia (CML), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), hairy cell leukemia, Burkitt's lymphoma, or lymphoblastic lymphoma - Serum folate <= 2.0 ng/mL or vitamin B12 <= 200 pg/mL at screening (anemia related to nutritional deficiencies) - Iron deficiency [transferrin saturation (TSAT) < 15% and serum ferritin < 10 ng/mL] at screening - Other diagnoses not related to cancer or chemotherapy, which cause anemia (ie, hemolysis, bleeding, sickle cell anemia) - Clinically significant inflammatory disease as determined by the investigator (eg, rheumatoid arthritis, Crohn's disease) - Clinically significant co-morbid medical or psychiatric conditions that may impact subject safety or confound the ability to evaluate study endpoint as determined by the investigator - Unstable or uncontrolled cardiac disease or condition (ie, angina, congestive heart failure, or cardiac arrhythmia) - Diastolic blood pressure > 100 mmHg at screening - Known hypersensitivity of erythropoietic-stimulating proteins (ESPs) or any excipients - Known history of pure red cell aplasia - Known positive antibody response to an ESP - Use of investigational agents not approved or any indication during the previous 30 days prior to enrollment - ESP therapy (i.e., recombinant human erythropoietin [rHuEPO] or darbepoetin alfa) within 21 days prior to screening or between screening and the first dose of study drug - RBC transfusion(s) within 21 days prior to screening - Pregnant or breast-feeding women - Previously enrolled in this study - Known to be HIV, hepatitis B or C positive - Any disorder that would compromise the ability of the subject to give written informed consent and comply with study requirements and procedures
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20040232 |
Study First Received: | October 13, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00239239 |
Health Authority: | United States: Food and Drug Administration |
Non-myeloid malignancy Chemotherapy-induced anemia Oncology Clinical Trials |
Pharmacokinetics Darbepoetin alfa Aranesp Amgen |
Hematologic Diseases Darbepoetin alfa Anemia |
Neoplasms Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |