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临床试验/EUCTR2011-001884-39-IT
EUCTR2011-001884-39-IT进行中(未招募)不适用

A phase II study of orally administered BEZ235 monotherapy in patients with metastatic or unresectable malignant PEComa

OVARTIS FARMA0 个研究点目标入组 33 人开始时间: 2012年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
OVARTIS FARMA
入组人数
33

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

  • Histologically confirmed diagnosis of malignant PEComa (included epithelioid angiomyolipoma (AML)) in adult patients; Unresectable/advanced and/or metatstatic and documented progressive measurable disease; Treated with 1 or 2 prior lines of treatment. Other protocol-defined inclusion criteria may apply.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 13
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Disease exclusions : lymphangioleiomyomatosis (LAM) exclusively, ative uncontrolled or symptomatic CNS metastases, concurrent malignancy or malignancy in last 3 years; Concurrent severe and/or uncontrolled medical conditions (for details see protocol). Other protocol-defined exclusion criteria may apply.

研究者

发起方
OVARTIS FARMA

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