NCT03776032已完成3 期
A Double-Blind, Placebo Controlled, Randomised Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Lung Cancer Subjects Receiving Multicycle Platinum-Containing 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
- 320
- 主要终点
- Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12
研究概览
简要总结
The primary objective of this study was to compare the effectiveness of darbopoetin alfa to placebo in the treatment of anemia in adults with lung cancer receiving multicycle platinum-containing chemotherapy, by assessing the percentage of participants who received red blood cell (RBC) transfusions during weeks 5-12 inclusive.
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
- Double (Participant, Investigator)
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
- •Lung cancer (either small cell [SCLC] or non-small cell [NSCLC])
- •At least 12 additional weeks of platinum containing cyclic chemotherapy planned regardless of cycle length
- •Anemia (hemoglobin ≤ 11.0 g/dL) as assessed by a local or central laboratory result within 7 days before study day 1 (the first scheduled day of on-study chemotherapy and the first day of study drug administration)
- •Life expectancy of at least 6 months, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Anemia predominantly due to the cancer or chemotherapy (i.e.. serum folate ≥ 4.5 nmol/L (≥ 2.0 ng/mL) and vitamin B 12 ≥ 148 pmol/L (≥ 200 pg/mL), no overt hemolysis, and no overt gastrointestinal bleeding or bleeding due to recent surgery)
- •Adequate renal function (creatinine ≤ 177gmol/L (≤ 2.0 mg/dL) and adequate hepatic function (bilirubin ≤ 1.5 times central laboratory's upper limit of normal range)
- •Available for 4 weeks post administration of the last dose of study drug
- •Legal age for informed consent, and written informed consent must be obtained
排除标准
- •History of any primary hematological disorder which could cause anemia (e.g., sickle cell anemia)
- •Received prior whole pelvis radiation therapy
- •Uncontrolled angina, congestive heart failure (New York Heart Association > class II or known ejection fraction < 40%)], or uncontrolled cardiac arrhythmia.
- •History of primary or metastatic malignancy involving the central nervous system (CNS). Subjects with a previous history of primary or metastatic malignancy involving the CNS will be eligible for the study providing they have had no clinical signs of nor treatment for CNS disease and no history of seizures within previous 2 years
- •Uncontrolled hypertension (i.e., diastolic blood pressure > 100 mm Hg)
- •History of seizures. Subjects with a previous history of seizures will be eligible for the study providing they have had no evidence of seizure activity and have been free of anti-seizure medication for the previous 5 years
- •Evidence of clinically significant systemic active infection or chronic inflammatory disease (e.g., rheumatoid arthritis)
- •Iron deficiency (transferrin saturation < 15% and ferritin < 10 μg/L (< 10 ng/mL))
- •Received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
- •Received erythropoietin therapy within 8 weeks before randomization
- •Known positive test for human immunodeficiency virus (HIV) infection
- •Receiving, or not yet 30 days past the end of receiving, another investigational agent or device not approved in any indication.
- •Pregnant or breast feeding females.
- •Not using adequate contraceptive precautions
- •Prior treatment with NESP
- •Previously randomized in this study
- •Known hypersensitivity to mammalian-derived product
- •Concerns for subject's compliance with the protocol procedure, including completion of the quality of life surveys (QOLS)
研究组 & 干预措施
Darbepoetin alfa
Experimental
Participants received once a week darbepoetin alfa, administered by subcutaneous injection at a starting dose of 2.25 µg/kg for up to 12 weeks. The dose of darbepoetin alfa may have been adjusted based on hemoglobin levels to a maximum dose of 4.5 µg/kg /week.
干预措施: Darbepoetin alfa (Drug)
Placebo
Placebo Comparator
Participants received once a week placebo, administered by subcutaneous injection for up to 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12
时间窗: Weeks 5 to 12
次要结局
- Time to First Red Blood Cell Transfusion During Weeks 5 to 12(Week 5 to week 12)
- Percentage of Participants who Achieved a Sustained Hemoglobin Correction by Week 12(12 weeks)
- Time to Sustained Hemoglobin Correction(12 weeks)
- Number of Standard Units of RBCs Transfused During Weeks 5 to 12(Weeks 5 to 12)
- Number of Days with RBC Transfusions During Weeks 5 to 12(Weeks 5 to 12)
- Change from Baseline in the Functional Assessment of Cancer Therapy (FACT)-Anemia Subscales at Week 12(Baseline and week 12)
- Time to Hemoglobin Correction(12 weeks)
- Percentage of Participants who Received a Red Blood Cell Transfusion During Weeks 1 to 4, 5 to 8, and 9 to 12(Weeks 1 to 4, 5 to 8, and 9 to 12)
- Change from Baseline in Hemoglobin at Week 12(Baseline and week 12)
- Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12(12 weeks)
- Time to Sustained Hemoglobin Response(12 weeks)
- Percentage of Participants with a Hemoglobin Response by Week 12(12 weeks)
- Time to Hemoglobin Response(12 weeks)
- Percentage of Participants who Achieved a Hemoglobin Correction by Week 12(12 weeks)
- Number of Participants with Adverse Events(16 weeks)
研究者
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