JPRN-UMIN000012551已完成2 期
A Phase II, Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Trastuzumab (Herceptin) in Patients with Her2 Overexpression/Amplification/Mutation-Positive, Pretreated, Non-Small Cell Lung Cancer (HER2-CLHERC-B/HOT1303-B) - Phase II Study of Trastuzumab for HER2-positive Non-Small Cell Lung Cancers (HER2-CLHERC-B/HOT1303-B)
Hokkaido Lung Cancer Clinical Study Group0 个研究点目标入组 10 人开始时间: 2013年12月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) ALK fusion positive 2) K-RAS mutation positive 3) Patients who have the following serious illness or medical condition; a) congestive heart failure or history of documented congestive heart failure b) angina pectoris requiring medication c) history of myocardial infarction d) poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg) e) clinically significant valvular heart disease f) high-risk uncontrolled arrhythmias. 4) Baseline left ventricular ejection fraction (LVEF) <50% 5) Exceeding critical dosage in prior treatment by the drug with cardiac toxicity such as anthracycline drugs 6) Interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray film or CT scan 7) Patients with dyspnoea at rest due to malignant or other disease or who require supportive oxygen therapy 8) Drug allergy career with inappropriateness for participation to this study 9) Active infectious disease that interferes to this treatment 10) Patients receiving chronic or high dose corticosteroid therapy (inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed) 11) Other serious medical complications (cerebrovascular disorder, active digestive ulcer, uncontrolled diabetes mellitus, psychological/mental illness that becomes obstacle for this study, etc) 12) HBsAg-positive; if HBcAb-positive and/or HBsAb-positive, HBV DNA-positive 13) Requirement for drainage therapy of pleural, abdominal or cardiac effusion. 14) Patients with symptomatic brain metastasis 15) Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recoverd from any acute toxicity) 16) Major surgery within 4 weeks of start of study treatment, without complete recovery 17) Patients with active concomitant malignancy 18) Pregnant, lactating women. 19) Inappropriate patients judged by physicians
研究者
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