NCT00035607已完成2 期
A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) 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
- 120
- 主要终点
- Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
研究概览
简要总结
This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Diagnosed with a non-myeloid malignancy
- •Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug
- •Screening hemoglobin concentration less than or equal to 11.0g/dL
- •ECOG performance status of 0 to 2
- •Adequate renal and liver function
排除标准
- •History of seizure disorder
- •Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1
- •More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1
研究组 & 干预措施
Darbepoetin alfa SC
Active Comparator
干预措施: Darbepoetin alfa SC (Drug)
Darbepoetin alfa IV
Experimental
干预措施: Darbepoetin alfa IV (Drug)
结局指标
主要结局
Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
时间窗: from baseline to the end of treatment period (EOTP)
次要结局
- Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration(throughout study)
- Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP(from baseline to week 7 and from week 7 to EOTP)
- Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period(during the treatment period)
- Time to and percentage of subjects with a hemoglobin response during the treatment period(during the treatment period)
- Percentage of subjects who exceed the hemoglobin threshold(throughout study)
- Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events(throughout study)
- Incidence, if any, of neutralizing antibody formation to darbepoetin alfa(throughout study)
研究者
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