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临床试验/EUCTR2011-002872-17-IT
EUCTR2011-002872-17-IT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 FARMA0 个研究点目标入组 124 人开始时间: 2013年4月4日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
OVARTIS FARMA
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 well differentiated carcinoma of the lung and thymus
  • Patients of all treatment lines can be included
  • 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 78
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 42

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

发起方
OVARTIS FARMA

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Clinical 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 thymuseouroendocrine carcinoma of the lung and thymusMedDRA version: 20.0Level: LLTClassification code 10025064Term: Lung carcinomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 100000004864
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