EUCTR2008-001721-34-BE进行中（未招募）1 期
A Phase 2, Randomised, Double-blind, Placebo-controlled, Dose-finding Study of Darbepoetin alfa for the Treatment of Anemia in Paediatric Subjects with Solid Tumours Receiving Cyclic Chemotherapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 225
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Disease Related
- •Diagnosed with Ewing’s sarcoma, neuroblastoma, osteosarcoma, soft tissue
- •sarcoma or medulloblastoma
- •Currently receiving non-myeloablative chemotherapy treatment and expecting
- •to receive at least a further 9 weeks of chemotherapy
- •Demographic
- •Male or female age 1 to 18 years of age at randomisation
- •ECOG performance status of 0, 1, or 2 assessed by the investigator at screening
- •Screening hemoglobin level = 10.0 g/dL. (If screening takes more than 7 days,
- •confirmation hemoglobin must be performed within 7 days before randomisation.)
- •A legal guardian willing and able to provide written informed consent and subject is
- •willing and able to provide written assent, when required. Written informed consent
- •and subject assent, when required, must be obtained from the legally accepted
- •representative before any study-specific procedures are performed
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease Related
- •Anemia related to nutritional deficiencies per investigator judgement
- •Planned myeloablative radiation therapy during the screening or treatment periods
- •Planned myeloablative therapy (eg bone marrow transplant) within 3 weeks following the last dose of investigational product
- •Diagnosis of conditions not related to chemotherapy which cause anemia (eg, gastrointestinal bleeding, renal disease)
- •Unstable cardiac condition per investigator judgement
- •Uncontrolled hypertension per investigator judgement
- •Documented history of pure red cell aplasia
- •History of clinically significant venous thromboembolic event (VTE) within 6 months
- •of screening (clinically significant VTE does not include superficial thrombosis)
- •Received any RBC transfusion within 21 days before randomisation
- •Plan to receive any RBC transfusion between randomisation and study day 1
- •Inadequate renal and/or liver function: creatinine > 2X ULN and/or transaminases
- •> 5X ULN (>10 X ULN if the subject is receiving methotrexate treatment)
- •Known positive test of human immunodeficiency virus (HIV)
- •Transferrin saturation < 15% and ferritin < 22.5 pmol/L (< 10 ng/mL) at screening.
- •Medications
- •Previous use of investigational agent(s) or devices not approved for any indication
- •during the 30 days prior to the first screening visit
- •Known previous treatment failure to erythropoiesis stimulating agent (ESA) (ie,
- •rHuEpo, darbepoetin alfa)
- •ESA therapy at any time during the 28 days prior to screening
- •Subjects of reproductive potential who are pregnant, breast feeding or not using
- •effective contraceptive precautions in the judgement of the investigator (including
- •females of childbearing potential who are partners of male subjects)
- •Previously randomised to this trial
- •Known hypersensitivity to recombinant ESAs or the excipients contained within the
- •investigational product
- •Confirmed history of neutralizing antibody activity to rHuEpo or darbepoetin alfa
- •Any condition that compromises the ability of the subject or legal representative to
- •give written informed consent and/or comply with study instructions and procedures
研究者
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