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临床试验/EUCTR2009-015296-26-IT
EUCTR2009-015296-26-IT进行中(未招募)不适用

MULTICENTRIC PROSPECTIVE DOSE-FINDING AND PHASE II STUDY WITH ORAL TOPOTECAN IN ADVANCED SMALL-CELL LUNG CANCER (SCLC) PATIENTS RECURRENT AFTER A FIRST LINE THERAPY - SCLC

AZIENDA USL 6 LIVORNO ZONA LIVORNESE0 个研究点开始时间: 2009年12月14日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • Histological or cytological confirmed small cell lung cancer; - Measurable disease with RECIST criteria; - Recurrent disease after a first line therapy; - Age < 75 years; - ECOG performance status 0-1; - Life expectancy of more than 3 months; - Adequate haematological function: WBC ≥ 4.0 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 10 g/dL; - Adequate liver and renal function: serum bilirubin ≤ 1.5 x ULN, serum creatinine ≤ 1.5 x mg/dl; - Written informed consent
  • 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

  • Patient not candidated to chemotherapic treatment; - Second malignancies; - More than one previous chemotherapeutic regimens

研究者

发起方
AZIENDA USL 6 LIVORNO ZONA LIVORNESE

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