EUCTR2007-005983-28-IT进行中（未招募）不适用
Phase IIb/III randomized, double-blind trial of BIBW 2992 plus best supportive care (BSC) versus placebo plus BSC in non-small cell lung cancer patients failing erlotinib or gefitinib - ND
BOEHRINGER ING.0 个研究点目标入组 480 人开始时间: 2008年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
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
- •-Patients with pathologic confirmation of NSCLC Stage III-B (with pleural effusion) adenocarcinoma or Stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum-based. -Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva) or gefitinib (Iressa) -Eastern Cooperative Oncology Group (ECOG) performance Score 0, 1 or 2 -Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as >=20 mm using conventional techniques or >=10 mm with spiral CT scan -Male and female patients age >=18 years -Life expectancy of at least three (3) months -Written informed consent that is consistent with ICH-GCP guidelines
- •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
- •-More than two (2) prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic NSCLC. -Use of erlotinib (Tarceva) or gefitinib (Iressa) within 14 days of treatment Day 1 -Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks -Active brain metastases (stable <4 weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization. -Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn?s disease, malabsorption, or CTCAE Grade >2 diarrhea of any etiology at baseline -Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug -Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer and in situ cervical cancer) -Radiotherapy within the past 2 weeks prior to treatment with the trial drug -History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3 -Cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram -QTc interval >=0.47 second -Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) >=400 mg/m2 -Absolute neutrophil count (ANC) <=1500 / mm**3 -Platelet count <=100,000 / mm**3 -Bilirubin >=1.5 mg /dl (>26 µmol /L, SI unit equivalent) -Aspartate amino transferase (AST) or alanine amino transferase (ALT) >= three times the upper limit of normal (if related to liver metastases >= five times the upper limit of normal) -Serum creatinine >=1.5 times of the upper normal limit or calculated/measured creatine clearance <=45ml/min -Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial -Pregnancy or breast feeding -Patients unable to comply with the protocol -Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C -Known or suspected active drug or alcohol abuse
研究者
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