A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 主要终点
- Average Hb change from baseline
研究概览
简要总结
This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.
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
- •>=18 years of age;
- •stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy;
- •myelosuppressive chemotherapy scheduled for at least 9 weeks;
- •anemia at screening visit.
排除标准
- •transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication;
- •iron deficiency anemia, or anemia caused by gastrointestinal bleeding;
- •prior treatment with Mircera.
研究组 & 干预措施
Mircera 6.3 micrograms/kg
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Mircera 9 micrograms/kg
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Mircera 12 micrograms/kg
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Darbepoetin alfa
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Average Hb change from baseline
时间窗: Weeks 5-13
次要结局
- Target Hb therapeutic range, average Hb values, hematopoietic response.(Days 2-85)
- Red blood cell (RBC) transfusions(Weeks 5-13)
- Adverse events (AEs), laboratory parameters, premature withdrawals(Throughout study)