NCT00239239已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 44
- 主要终点
- To characterize the PK of darbepoetin alfa administered at a SC dose of 0.45 mcg/kg TIW in the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
test treatment period
Experimental
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
To characterize the PK of darbepoetin alfa administered at a SC dose of 0.45 mcg/kg TIW in the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy
时间窗: 18 weeks
次要结局
- To assess the effect of darbepoetin alfa treatment on hematopoietic response, red blood cell (RBC) transfusion requirements, and the safety of darbepoetin alfa in subjects receiving multicycle chemotherapy(18 weeks)
研究者
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