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临床试验/EUCTR2011-002872-17-GB
EUCTR2011-002872-17-GB进行中(未招募)1 期

Multicenter 3-arm trial to evaluate the efficacy and safety of Pasireotide LAR or Everolimus alone or in combination in patients with well differentiated neuroendocrine carcinoma of the lung and thymus -LUNA Trial

ovartis Pharma Services AG0 个研究点目标入组 124 人开始时间: 2013年3月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
124

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 confirmed advanced typical and atypical carcinoid tumours of the lung and thymus
  • Patients of all treatment lines can be enrolled
  • At least one measurable lesion of disease on CT scan or MRI
  • Radiological documentation of disease progression within 12 months prior to randomization
  • Adequate liver, renal and bone marrow function
  • WHO Performance Status 0-2
  • Other protocol-defined inclusion criteria may apply
  • 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 80
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 44

排除标准

  • Poorly differentiated neuroendocrine carcinoma
  • Non-neuroendocrine thymoma
  • Patients with severe functional disease requiring symptomatic treatment with somatostatin analogs
  • Prior therapy with mTOR inhibitors
  • History of liver disease
  • Baseline QTcF> 470 msec
  • Uncontrolled diabetes mellitus despite adequate therapy
  • Other protocol-defined exclusion criteria may apply

研究者

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