A Single Arm, Open Label Multicentre Extension Study of Bevacizumab in Patients With Solid Tumours on Study Treatment With Bevacizumab, at the End of A F. Hoffmann-La Roche and/or Genentech Sponsored Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 73
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator
- •Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol
- •Able to comply with this extension study protocol (MO25757)
排除标准
- •Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study
- •Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation
- •A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial
- •Evidence of any other disease that would put the participant at high risk for treatment-related complications
研究组 & 干预措施
Breast Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
干预措施: Bevacizumab (Drug)
Glioblastoma Multiforme
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
干预措施: Bevacizumab (Drug)
Ovarian Cancer or Peritoneal Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
干预措施: Bevacizumab (Drug)
Renal Cell Carcinoma
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
干预措施: Bevacizumab (Drug)
Colorectal Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
干预措施: Bevacizumab (Drug)
Non-Squamous, Non-Small Cell Lung Cancer
Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: Baseline up to approximately 81 months
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
次要结局
- Progression Free Survival (PFS)(Baseline up to approximately 81 months)
- Overall Survival (OS)(Baseline up to approximately 81 months)