A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 707
- 主要终点
- Time to first hemoglobin response during the treatment period
研究概览
简要总结
Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.
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
- 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
- •Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug
- •Screening hemoglobin concentration less than or equal to 11.0 g/dL
- •ECOG performance status of 0 to 2 (inclusive)
排除标准
- •History of seizure disorder
- •Primary hematologic disorder that could cause anemia
- •Unstable or uncontrolled disease/condition related to or affecting cardiac function
- •Clinical evidence of chronic infection/inflammatory disease
- •Positive test for HIV infection
- •Previously confirmed neutralizing antibodies to rHuEPO
- •Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 RBC transfusion occurences
研究组 & 干预措施
rHuEPO
干预措施: rHuEPO (Drug)
Darbepoetin alfa
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Time to first hemoglobin response during the treatment period
时间窗: during the treatment period
次要结局
- Average weekly dosage of study drug during the 16-week treatment period(16-week treatment period)
- Receiving red blood cell (RBC) transfusion from week 5 to week 12(from week 5 to week 12)
- Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP)(from baseline to EOTP)
- Number of units of RBC transfused during the treatment period(during the treatment period)
- Number and percentage of subjects who exceed the hemoglobin concentration threshold(throughout study)
- Change in FACT-Physical Well-being scale score from baseline to EOTP(from baseline to EOTP)
- Receiving RBC transfusion during the treatment period(during the treatment period)
- Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events(throughout study)
- Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO)(throughout study)
- Change in FACT-Fatigue scale score from baseline to week 7(from baseline to week 7)
- Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise(throughout study)
- Profile of change in FACT-Fatigue scale score from baseline over the treatment period(from baseline over the treatment period)
- Achieving a hemoglobin response by week 7(baseline to week 7)
- Change in hemoglobin concentration from baseline to EOTP(from baseline to EOTP)
- Time to first hematopoietic response(throughout study)
- Achieving a hemoglobin correction(throughout study)