PER-082-09已完成未知
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy
AMGEN INC.,0 个研究点目标入组 0 人开始时间: 2009年10月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 80（—）
入选标准
- •Subjects in metastatic stage (stage IV) or advanced stage IIIB with NSCLC malignant pleural effusion
- •Under treatment or about to receive first-line cyclic chemotherapy for NSCLC and expected to receive at least 2 additional cycles of cyclic chemotherapy
- •Life expectancy> 6 months based on the investigator´s judgment and documented during the scrutiny
- •Status performance of the Eastern Cooperative Cancer Group (ECOG) of 0 or 1 as assessed during the scrutiny
- •18 years of age or older during scrutiny
- •Subjects with chemotherapy-induced anemia defined by a hemoglobin level <11.0 g / dL during screening. If the screening takes more than 7 days, a hemoglobin confirmation level must be performed within 7 days of randomization.
- •Subjects must have a documented hemoglobin value before chemotherapy (obtained within 4 weeks prior to the start of first-line chemotherapy for NSCLC)
- •Subjects must have a baseline scan (CT, MRI or PET / CT of the upper chest and abdominal) to assess the burden of disease before starting first-line chemotherapy for NSCLC and such images should be available to the investigator
- •Levels of serum folate> 2 ng / mL) and vitamin B12 (> 200 pg / mL) appropriate at the screening evaluated by the central laboratory (supplement and reexamination acceptable)
- •Before any specific study procedure, informed consent must be obtained from the subject in writing or from the valid legal representative
排除标准
- •Known malignant or benign primary hematologic disorder that could cause anemia
- •History of cancer or current active cancer (other than non-small cell lung cancer), with the exception of non-melanomatous skin cancer with curative resection, cervical carcinoma treated curatively in situ or other primary solid tumors treated curatively, without known active disease present and without curative treatment administered during the last 3 years.
- •Subjects with a history of brain metastasis
- •Uncontrolled hypertension (systolic blood pressure (BP)> 160 mmHg or diastolic BP> 100 mmHg), or as determined by the investigator during screening
- •History of activity of neutralizing antibodies to rHuEPO or Darbepoietin alfa
- •Uncontrolled angina, uncontrolled heart failure or uncontrolled cardiac arrhythmia as determined by the investigator during screening. Subjects with myocardial infarction within 6 months prior to scrutiny.
- •Subjects with a history of seizure disorder who have received anticonvulsant medications within 30 days of scrutiny
- •Clinically important systemic infection or uncontrolled chronic inflammatory disease (eg rheumatoid arthritis, irritable bowel) at the time of screening as determined by e! investigator
- •Known seropositivity to human immunodeficiency virus (HIV), or diagnosis of acquired immunodeficiency syndrome (AIDS). Positive for superficial hepatitis B antigen or seropositive for hepatitis virus
- •History of pure red series aplasia
- •History of deep venous thrombosis or embolic event (for example: pulmonary embolism) during the 6 months prior to scrutiny
- •Known failure to a previous treatment for ESAs (eg rHuEPO, Darbepoietin alfa)
- •ESA therapy during the 28 days prior to scrutiny
- •Known hypersensitivity to recombinant ESAs or to the excipients contained in the research product
- •Transferrin saturation <20% and fem´tine <50 ng / mL at screening. Subjects should have both excluded (supplement and reexamination acceptable)
- •Abnormal renal foundry (serum creatinine level> 2 times the upper limit of normal [ULN]) during screening
- •Abnormal liver function (total bilirubin> 2X ULN and liver enzymes alanine aminotransferase [ALT] or aspartate aminotransferase [AST]> 2.5X ULN for subjects without liver metastases or> 5X ULN for subjects with liver metastases) during scrutiny. Subjects with documented Gilbert´s syndrome may be eligible.
- •Have received any RBC transfusion within 28 days prior to randomization
- •Plan to receive any RBC transfusion between randomization and day 1 of the study
- •That they have less than 30 days of receiving any research product or device. The use / reception for research of a product or medical device that has been approved by the country´s local regulatory authorities for any indication is allowed
- •People of childbearing age who are pregnant, breastfeeding or who do not wish to have effective contraceptive precautions during the study and for at least one month after the last dose of the investigational product at the investigator´s discretion (including women of childbearing age who are partners of the male subjects)
- •Prior randomization in this study
- •The researcher´s doubts regarding the subject´s ability to provide written informed consent and / or to comply with the study procedures (including availability for follow-up visits)
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