EUCTR2010-023218-30-IT进行中（未招募）1 期
Phase II trial exploring the sequence of bevacizumab and lomustine in patients with first recurrence of a glioblastoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- EORTC
- 入组人数
- 249
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 de novo glioblastoma (primary) with unequivocal first progression after RT concurrent/adjuvant chemotherapy at least 3 months off the concomitant part of the radiochemotherapy
- •- Availability of biological material for central review processes and translational research projects
- •- Patient may have been operated for recurrence. If operated:
- •* residual and measurable disease after surgery is not required but surgery must have confirmed the recurrence
- •* a post-surgery MRI should be available within 48 hours following surgery
- •* Surgery completed at least 2 weeks before registration and patients should have fully recovered
- •- Craniotomy or intracranial biopsy site must be adequately healed free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomisation.
- •- Absence of any cardiovascular disorder
- •- Absence of any thrombotic or hemorrhagic event
- •- Absence of known hypersensitivity:
- •* to any part of the bevacizumab or lomustine formulations.
- •* to Chinese hamster ovary cell products or other recombinant human or humanized antibody.
- •- Age = 18 years
- •- WHO Performance status 0 - 2
- •- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. In general, the decision for appropriate methods to prevent pregnancy should be determined by discussions between the investigator and the study subject. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy,
- •bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Females should not be breast feeding.
- •- Males must agree to use an effective method of contraception during the treatment period and for at least 6 months after the last study treatment.
- •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 126
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •- More than one line of chemotherapy (concurrent and adjuvant temozolomide based chemotherapy including in combination with another investigational agent is considered one line of chemotherapy). Chemotherapy must have been completed at least 4weeks prior to randomization.
- •- Current or recent (within 4 weeks before randomization) treatment with another investigational drug
- •- Prior treatment with bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors
- •- Radiotherapy within the three months prior to the diagnosis of progression
- •- Radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven
研究者
相似试验
已完成
2 期
Phase II trial of the addition of bevacizumab to alectinib beyond progressive disease in ALK-positive advanced non-small-cell lung cancer.ALK-positive non-small cell lung cancerJPRN-UMIN000017828iigata Lung Cancer Treatment Group11
尚未招募
不适用
Phase 2 trial of utility and safety for bevacizumab in combination with adjuvant chemotherapy in cervical cancerCervical cancerJPRN-UMIN000026986Osaka medical college50
进行中（未招募）
不适用
A randomized phase III clinical study of bevacizumab plus capecitabine vs. bevacizumab alone as maintenance therapy in patients with HER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy. - IMELDAHER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy.MedDRA version: 12.1Level: LLTClassification code 10055113Term: Breast cancer metastaticEUCTR2008-006872-31-ITF. Hoffmann - La Roche Ltd420
进行中（未招募）
1 期
A randomized phase III clinical study of bevacizumab plus capecitabine vs. bevacizumab alone as maintenance therapy in patients with HER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy. - IMELDAHER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy.MedDRA version: 9.1Level: LLTClassification code 10055113Term: Breast cancer metastaticEUCTR2008-006872-31-FRF. Hoffmann-La Roche Ltd287
进行中（未招募）
不适用
Phase II randomized study of intravenous bevacizumab with sequential versus concurrent oral vinorelbine plus capecitabine in patients with locally advanced or recurrent breast cancer with lymphangitic spread to the chest wall. - NDlocally advanced or recurrent breast cancer with lymphangitic spread to the chest wall.MedDRA version: 9.1Level: LLTClassification code 10006279Term: Breast neoplasmEUCTR2006-002152-16-ITISTITUTO EUROPEO DI ONCOLOGIA