A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
研究概览
简要总结
The purpose of this study is to assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy.
详细描述
Patients with non curable solid tumors or lymphoma with anemia (hemoglobin < 10g/dl) undergoing palliative care chemotherapy will enter this 12 week single arm open label study. Epoetin alfa 40.000-60.000 IU/week will be administered subcutaneously and controlled every 2 weeks. Up or down titration will be performed according to the currently approved prescription guidance for a total of 12 weeks of treatment. Study end points will be assessed every 4 weeks until final 12 week visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Confirmed diagnosis of non curable cancer or lymphoma
- •Receiving a palliative chemotherapy regimen
- •Hemoglobin < 10.0 g/dL
- •Performance ≤ 3 of Eastern Cooperative Oncology Group (ECOG) performance status
- •Life expectancy of ≥ 3 months
- •Postmenopausal o premenopausal women receiving effective contraceptive method
排除标准
- •Active bleeding that may have caused anemia in the prior 30 days.
- •Uncontrolled hypertension
- •Anemia for another cause other than cancer or chemotherapy
- •Untreated iron or folic acid deficiency
- •Transfusion in the last 30 days prior to baseline visit
- •Treatment with an erythropoiesis stimulating agent 3 months prior to the baseline visit
- •Increased risk of thromboembolic disease
- •Radiotherapy in pelvis or spine in the last 60 days
- •Myelodysplasic syndrome
- •History of congestive heart failure
- •Pregnant or lactating
- •Patient with known allergy to human albumin or related products
结局指标
主要结局
Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
时间窗: Baseline to 12 weeks
次要结局
- Quality of life(12 Weeks)
- Hemoglobin levels and percentage of responders(Every 4 weeks and 12 weeks)
- Hemoglobin levels ≥ 2 g/dl(12 weeks)