NL-OMON30640尚未招募2 期
Randomized phase II study of amrubicin as single agent or in combination with cisplatin versus etoposide-cisplatin as first-line treatment in patients with extensive stage SCLC (ES). - amrubicin, amrubicin-cisplatin versus etoposide-cisplatin in SCLC
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
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 99（—）
入选标准
- •-Histologically/cytologically proven small cell lung cancer
- •-WHO performance status 0-2
- •-Measurable disease according to RECIST criteria
- •-Age > 18 years
- •-Normal baseline cardiac function
- •-Adequate haematological function (WBC >1.5 x 10 9/L, platelets >100 x 10 9/L, Hb >9 g/dL)
- •-Creatinine clearance: > 60 ml/min (Cockcroft and Gault)
- •-Adequate hepatobiliary function (ALAT/AST <2.5 x Upper Limit of Normal)
- •-Written informed consent before randomization, according to ICH/EU GCP and national/local regulations
排除标准
- •-No prior systemic chemotherapy for small cell lung cancer
- •-No history of interstitial lung disease or pulmonary fibrosis
- •-No history of prior malignancy unless patient has been disease free for >5 years, or the tumour was a non-melanoma skin cancer or in-situ carcinoma of the cervix
- •-Absence of pre-existing peripheral neuropathy (CTCAE version 3.0 grade >1)
- •-Absence of uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, clinical significant pericardial disease or cardiac amyloidosis
- •-No pregnancy or breast feeding. Men and women of child bearing potential must use an appropriate method of contraception if the risk of conception exists
研究者
相似试验
进行中（未招募）
不适用
Randomized phase II study of amrubicin as single agent or in combination with cisplatin versus etoposide-cisplatin as first-line treatment in patients with extensive stage SCLC ES - NDPatient with small cell lung cancer.MedDRA version: 6.1Level: PTClassification code 10041068EUCTR2006-001956-11-ITCABRELLIS PHARMACEUTICALS CORPORATIO85
进行中（未招募）
不适用
Randomized Phase II Study of Amrubicin as Single Agent or in Combination with Cisplatin versus Etoposide-Cisplatin as first-Line Treatment in Patients with Extensive Stage SCLCSmall Cell Lung Cancer (extensive stage)MedDRA version: 8.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stageEUCTR2006-001956-11-NLCabrellis Pharmaceuticals Corporation85
进行中（未招募）
不适用
Randomized Phase II Study of Amrubicin as Single Agent or in Combination with Cisplatin versus Etoposide-Cisplatin as first-Line Treatment in Patients with Extensive Stage SCLCSmall Cell Lung Cancer (extensive stage)MedDRA version: 8.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stageEUCTR2006-001956-11-BECelgene International SAR97
进行中（未招募）
1 期
Randomized Phase II Study of Amrubicin as Single Agent or in Combination with Cisplatin versus Etoposide-Cisplatin as first-Line Treatment in Patients with Extensive Stage SCLCEUCTR2006-001956-11-GBCelgene International SAR97
已完成
2 期
A phase II study of amrubicin for previously treated small cell lung cancerFor patients with recurrent small cell lung cancerJPRN-UMIN000001752Gunma University Hospital35