JPRN-UMIN000005606已完成1 期
PhaseI/IIstudy of AMR in elderly patients with small-cell lung cancer previously treated with platina-based chemotherapy - PhaseI/IIstudy of AMR in elderly patients with small-cell lung cancer previously treated with platina-based chemotherapy
ung Oncology Group in Kyushu, Japan (LOGIK)0 个研究点目标入组 38 人开始时间: 2011年5月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
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
- 70years-old 至 ot applicable(—)
- 性别
- Female
入选标准
- 未提供
排除标准
- •(1)Previously treated with amrubicin hydrochloride (2)Interstitial pneumonia or pulmonary fibrosis suspected on chest CT (3)Abnormal cardiac function, myocardial infarction, or history thereof (4)Received the maximum allowed cumulative dose* of cardiotoxic drugs such as anthracycline derivatives in prior therapy *Maximum allowed cumulative doses are 25 mg/kg (body weight) for daunorubicin hydrochloride, 500 mg/m2 (body surface area) for doxorubicin hydrochloride, 900 mg/m2 for epirubicin hydrochloride, and 950 mg/m2 for pirarubicin hydrochloride (5)Symptomatic brain metastases (6)Pleural effusion, ascites, or pericardial effusion requiring drainage(7)Serious complications (cancerous pericarditis, superior vena cava syndrome, serious infection) (8)History of drug allergy judged unacceptable for participation in the study (9)Pregnant, possibly pregnant, or desire to become pregnant (10)For other reasons judged by the investigator (principal investigator or subinvestigator) to be inappropriate for this study (11)Active multiple cancers treated within the past 5 years as of the day of enrollment or during treatment with amrubicin hydrochloride (12)Uncontrolled diabetes mellitus, chronic steroid use
研究者
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