NCT00110955已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 391
- 主要终点
- Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
研究概览
简要总结
The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects with non-myeloid malignancy
- •At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
- •Hemoglobin concentration less than 11.0 g/dL within 24 hours before randomization
- •Adequate serum folate and vitamin B12
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Of legal age at the time written informed consent is obtained
排除标准
- •Known history of seizure disorder
- •Known primary hematologic disorder causing anemia other than non-myeloid malignancies
- •Unstable/uncontrolled cardiac condition
- •Clinically significant inflammatory disease
- •Other diagnoses not related to the cancer which can cause anemia
- •Inadequate renal and liver function
- •Iron deficiency
- •Known positive test for HIV infection
- •Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
- •Received more than 2 red blood cell (RBC) transfusions within 4 weeks of randomization; or any RBC transfusion within 14 days before randomization; or any planned RBC transfusion between randomization and study day 1
- •Received any erythropoietic therapy within 4 weeks of study day 1 or any planned erythropoietic therapy between randomization and study day 1
- •Other investigational procedures
- •Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject receiving other investigational agent(s)
- •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
研究组 & 干预措施
Darbepoetin alfa - Group A
Experimental
干预措施: Darbepoetin alfa (Drug)
Placebo- Group B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
时间窗: from week 5 to EOTP
次要结局
- Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP(from week 5 to EOTP)
- Number of RBC transfusions from week 5 to EOTP(from week 5 to EOTP)
- Change in FACT-Fatigue subscale score from baseline to EOTP(from baseline to EOTP)
- Change in FACT-G Physical Well-being subscale from baseline to EOTP(from baseline to EOTP)
- Incidence and severity of adverse events(throughout study)
- Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study(at any time on study)
- Change in FACT-G total score from baseline to EOTP(from baseline to EOTP)
- Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences(throughout study)
- Change in EQ-5D Thermometer from baseline to EOTP(from baseline to EOTP)
- Change in BSI Anxiety scale score from baseline to EOTP(from baseline to EOTP)
- Change in BSI Depression scale score from baseline to EOTP(from baseline to EOTP)
- Change in number of caregiver hours from baseline to EOTP(from baseline to EOTP)
- Incidence of a confirmed antibody formation to darbepoetin alfa(throughout study)
研究者
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