A Randomised, Double-blind, Placebo-controlled, Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) Administered by Subcutaneous (SC) Injection for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 405
- 主要终点
- Occurence of adverse events and antibody formation to NESP
研究概览
简要总结
The purpose of this study is to assess the safety of NESP administered by SC injection in subjects with solid tumours and anaemia receiving multicycle chemotherapy.
Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Schedule 1 is a sequential dose escalation study which consists of Parts A and B. Part A is the initial treatment phase, where the clinically effective dose (CED) of NESP administered every 3 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.
Schedule 2 is a parallel dose-finding study and also consists of Parts A and B. Part A is the initial treatment phase, where the CED of NESP administered every 4 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 接受健康志愿者
- 否
入选标准
- •Subject with solid tumour(s)
- •Anaemia (hgb less than or equal to 11.0 g/dL
- •Planned to receive cyclic chemotherapy
- •At least 6-month life expectancy
- •Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
- •Adequate renal and liver function
- •At least 18 years of age
排除标准
- •Central nervous system disease
- •Iron deficiency
- •Received more than 2 RBC transfusions within 4 weeks before randomisation or any RBC transfusion within 2 weeks before randomisation
- •Received recombinant human erythropoietin (rHuEPO) therapy within 8 weeks before randomisation
- •History of any seizure disorder
- •Cardiac disease
- •Active infection or inflammatory disease
- •Known positive test for HIV infection
- •Known primary haematologic disorder which could cause anaemia
- •Use of other investigational agent(s)/device(s)
- •Pregnant or breast feeding
- •Known hypersensitivity to any recombinant mammalian derived product
研究组 & 干预措施
NESP - Schedule 1 Part A
Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks
干预措施: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) (Drug)
NESP - Schedule 2 Part A
NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks
干预措施: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) (Drug)
Placebo - Schedule 1 Part A
Placebo Q3W for 12 weeks
干预措施: Placebo (Drug)
NESP - Schedule 1 Part B
Open-label NESP at the dose of study drug administered at the end of Part A. Increase dose at week 19 if hgb < 13.0g/dL and/or RBC transfusion in previous 2 weeks.
干预措施: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) (Drug)
Placebo - Schedule 2 Part A
Placebo Q4W for 12 weeks
干预措施: Placebo (Drug)
NESP - Schedule 2 Part B
Open-label NESP at the dose of study drug administered at the end of Part A
干预措施: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa) (Drug)
结局指标
主要结局
Occurence of adverse events and antibody formation to NESP
时间窗: throughout the study
次要结局
- Relationship between these QOL measurements and hgb
- Selected domains of quality of life (QOL) measured by FACT-G and FACT-anaemia scales, BSI depression and BSI anxiety scales, and de novo questions(throughout the study)
- Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response(during the treatment phase)
- Number and proportion of subjects who receive any RBC transfusion, number of units of RBC transfused, and number of days with at least one RBC transfusion during weeks 1-12, 1-4, 5-8, 9-12, and 5-12, with emphasis on the 5-12 week window(during weeks 1-12, 1-4, 5-8, 9-12, and 5-12)
- Hgb correction to greater than or equal to 12.0 g/dL in the absence of a red blood cell (RBC) transfusion during the preceding 4 weeks during treatment phase(during treatment phase)
- Time to hgb response and hgb correction after the initiation of treatment(after the initiation of treatment)
- Change in hgb measured at the end of the treatment phase compared to baseline(baseline to end of the treatment phase)