跳至主要内容
临床试验/EUCTR2012-003138-17-FI
EUCTR2012-003138-17-FI进行中(未招募)不适用

A double-blind, placebo-controlled, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care (SOC) +/-continuous bevacizumab treatment following progression of disease (PD) in patients with glioblastoma (GBM) after first (1st)-line treatment with radiotherapy, temozolomide and bevacizumab

F. Hoffmann-La Roche Ltd0 个研究点目标入组 510 人开始时间: 2013年5月20日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
510

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

  • Have provided written informed consent.
  • Age = 18 years .
  • Karnofsky performance status (KPS) = 60.
  • Newly diagnosed GBM
  • Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days and = 49 days following the last surgical procedure.
  • 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 398
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 112

排除标准

  • Any prior chemotherapy for GBM and low grade astrocytomas.
  • Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field.
  • Prior or current anti-angiogenic treatment (i.e. anti-VEGF or VEGFR therapies or tyrosine kinase inhibitors).
  • Evidence of recent brain haemorrhage
  • Acute cardiac disease

研究者

相似试验

进行中(未招募)
1 期
Clinical study evaluating if the patient is better and lives longer if bevacizumab is continued to be added to the standard treatment for worsening brain cancerMedDRA version: 14.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Glioblastoma
EUCTR2012-003138-17-ITF. Hoffmann-La Roche Ltd510
进行中(未招募)
1 期
Clinical study evaluating if the patient is better and lives longer if bevacizumab is continued to be added to the standard treatment for worsening brain cancerGlioblastoma
EUCTR2012-003138-17-HRF. Hoffmann-La Roche Ltd510
进行中(未招募)
1 期
Clinical study evaluating if the patient is better and lives longer if bevacizumab is continued to be added to the standard treatment for worsening brain cancerMedDRA version: 16.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Glioblastoma
EUCTR2012-003138-17-GRF. Hoffmann-La Roche Ltd510
进行中(未招募)
1 期
A comparison of continuous Avastin treatment or placebo in addition to lomustine followed by standard treatment for worsening brain cancerMedDRA version: 19.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Glioblastoma
EUCTR2012-003138-17-EEF. Hoffmann-La Roche Ltd300
进行中(未招募)
1 期
A comparison of continuous Avastin treatment or placebo in addition to lomustine followed by standard treatment for worsening brain cancer.MedDRA version: 17.0Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Glioblastoma
EUCTR2012-003138-17-IEF. Hoffmann-La Roche Ltd296
Clinical study evaluating if the patient is better... | 临床试验