EUCTR2007-002700-18-FR进行中（未招募）不适用
An Open-Label, Sequential, Ascending dose study, to Evaluate the safety, Pharmacokinetics, and Dose Response, of fixed, Repeated Doses of NE-180 (GlycoPEGylated™rHuEPO) in Anemic Cancer Patients Receiving Chemotherapy.
eose Technologies, Inc.0 个研究点目标入组 45 人开始时间: 2007年7月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- •1.Male or female patients must be = 18 and = 80 years of age at the time of consent
- •2.Patients must have a body weight = 40 and = 90 kgs
- •3.Patients must have a diagnosis of histologically-confirmed solid tumor or non-myeloid malignancy
- •4.Patients must be on a 4-6 cycle regimen of myelosuppressive chemotherapy (platin or non-platin-based chemotherapy is permitted) with a dosing schedule of every three weeks. Upon enrollment to the treatment phase (week 0), patients are expected to receive at least 4 additional cycles of chemotherapy.
- •5.Patients must have anaemia defined as baseline haemoglobin level of = 9.0 and = 11.0 g/dL within one week prior to administration of study drug.
- •6.Patients are expected to be treated with intravenous (IV) iron throughout the treatment phase.
- •7. Patients must have an Eastern Co-operative Oncology Group (ECOG) performance status of 0,1 or 2
- •8.Patients must have a life expectancy of 6 months or more
- •9.If female, the patient must;
- •a)be postmenopausal for at least one year, or
- •b)have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or
- •c)have practiced one of the following methods of contraception for at least one month prior to study entry (screening visit): hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility, and agree to agree to use two of these described contraceptive methods throughout the study, or
- •d)be practicing abstinence and agree to continue abstinence or to use two of the acceptable methods of contraception (as listed above) should sexual activity commence.
- •e)have a negative serum pregnancy test at time of screening.
- •10. After full explanation of the study, patients must understand the nature of the study and have signed the informed consent to participate
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients who received treatment with erythropoietic stimulating agents (ESA) within the last 90 days
- •2.Patients with known antibodies to other ESAs or history of Pure Red Cell Asplasia
- •3.Patients who received two or more RBC transfusions within 4 weeks of screening or any RBC transfusion within 14 days of screening
- •4.Patients with iron deficiency defined as baseline TSAT <20%
- •5.Patients with baseline serum creatinine > 2.0 mg/dL
- •6.Patients with baseline ALT or AST > 2.5 times the upper limit of normal, or ALT or AST > 5 times the upper limit of normal if liver metastases are present
- •7.Patients who have a history of poorly controlled hypertension per the investigator’s judgement within 4 weeks prior to screening
- •8.Patients with a history of pulmonary embolism or deep vein thrombosis within the previous two years or currently on therapeutic doses of anticoagulants
- •9.Patients with active cardiac disease as defined by a history of myocardial infarction, peripheral ischemia requiring angioplasty or surgery, mesenteric ischemia , or stroke within 6 months prior to screening
- •10.Patients with a history of congestive heart failure (NYHA class III or IV)
- •11.Known history or current diagnosis of anaemia attributed to a haematologic disorder or other etiology other than the current malignancy or chemotherapy treatment.
- •12.Patients with active infection, or any chronic inflammatory disorder
- •13.Patients with a history of seizure disorder
- •14.Patients who have participated in an investigational study within 30 days of the anticipated first dose of the study drug, or are planning participation during the study period
- •15.Patients with a known positive test for HIV and patients who are know to be hepatitis B or C carrriers
- •16.Patients who have a known allergy or hypersensitivity to the study drug and/or any of its components
- •17.Patient is pregnant or lactating
- •18.Patient is taking a drug/s not approved by the appropriate regulatory authority
- •19.Other factors which may affect participation, such as mental or legal incapacitation, drug or alcohol abuse within the last 2 years, or, in the investigator’s opinion, patients who may not be capable of following the study’s schedule for any reason.
研究者
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