EUCTR2011-001884-39-ES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 Farmaceutica S.A.0 个研究点目标入组 33 人开始时间: 2012年10月15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
- 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
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
- •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
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
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 inclusion/exclusion criteria may apply
- •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 inclusion/exclusion criteria may apply
研究者
相似试验
已完成
2 期
A phase II study of orally administered BEZ235 monotherapy in patients with metastatic or unresectable malignant PEComaPerivascular epithelioid cell tumors (PEComa)soft tissue tumor10072990NL-OMON37195ovartis3
进行中（未招募）
不适用
Safety and efficacy of BEZ235 in patients with perivascular epithelioid cell tumors (PEComas)EUCTR2011-001884-39-NLovartis Pharma Services AG33
进行中（未招募）
不适用
Safety and efficacy of BEZ235 in patients with perivascular epithelioid cell tumors (PEComas)EUCTR2011-001884-39-HUovartis Pharma Services AG33
进行中（未招募）
不适用
Safety and efficacy of BEZ235 in patients with perivascular epithelioid cell tumors (PEComas)Adult patient with metastatic or unresectable malignant perivascular epithelioid cell tumors (PEComa)MedDRA version: 14.1Level: PTClassification code 10039491Term: SarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-001884-39-ITOVARTIS FARMA33
进行中（未招募）
不适用
A Phase II study of orally administered BEZ235 monotherapy in patients with hormone receptor positive, HER2 negative, metastatic breast cancer, with or without PI3K activated pathwaypatients with hormone receptor positive, HER2 negative, metastatic breast cancer, with or without PI3K activated pathwayMedDRA version: 13.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-024394-39-GBovartis Pharma Services AG120