EUCTR2006-001659-37-IT进行中（未招募）不适用
Phase II Study of ZK 219 477 in patients with recurrent glioblastoma - Epothilone in GBM
E.O.R.T.C. - EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENT OF CANCER0 个研究点目标入组 35 人开始时间: 2007年6月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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
- •Patients with histologically proven glioblastoma.
- •♦ Recurrent disease documented by MRI after failing prior therapy
- •(usually standard RT with concomitant and maintenance
- •temozolomide).
- •♦ Patients with multifocal disease not amenable to radiotherapy are
- •eligible, provided they have received no or no more than 1 line of prior
- •chemotherapy.
- •♦ Presence of at least one bidimensionally measurable target lesion
- •(contrast enhancing lesion) with a largest diameter of at least 2cm,
- •based on MRI scan done within two weeks prior to the registration
- •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
- •No prior treatment with high dose radiotherapy (> 65 Gy), stereotactic
- •radiosurgery or internal radiation therapy unless the recurrence is
- •EORTC 26061 Epothilone in GBM
- •Version 1.0 8 / 67 31 May, 2006
- •subsequently histologically confirmed.
- •♦ Patients must not be taking antiepileptic agents or be on non-enzyme
- •inducing antiepileptic drugs (non-EIAED). Patients taking phenytoin,
- •carbamazepin or phenobarbital are not eligible.
- •No previous or current malignancy at other sites with the exception of
- •cone biopsied carcinoma of the cervix and adequately treated basal or
- •squamous cell skin carcinoma.
- •Females must not be pregnant at entry or lactating.
研究者
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