An Open-label, Multicenter Extension Study of Onartuzumab in Patients With Solid Tumors on Study Treatment Previously Enrolled in an F.Hoffmann-la Roche- and/or Genentech- Sponsored Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 10
- 主要终点
- Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab
研究概览
简要总结
This extension study will provide continued onartuzumab and/or parent trial (P-trial) designated control treatments to participants with cancer who were previously enrolled in a company-sponsored onartuzumab P-trial and who derived benefit, as assessed by the responsible investigator, from the therapy administered in the P-trial. The study will also collect safety data with regard to administration of continued onartuzumab therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Enrolled and receiving either control treatment or onartuzumab-based study treatment in an eligible P-trial
- •Has not met the treatment discontinuation criteria specified in their P-trial protocol at the time of enrollment into the extension trial (E-trial)
- •Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol
- •For women who are not postmenopausal (greater than or equal to [>/=] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of less than (<) 1 percent (%) per year during the treatment period and for at least 180 days after the last dose of study drug
- •For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 180 days after the last dose of study drug and agreement to refrain from donating sperm during this same period
排除标准
- •Pregnancy or lactation or intention to become pregnant during the study (serum pregnancy test required before enrollment)
- •Any non-protocol anti-cancer therapy started between discontinuation from treatment in P-trial and start of enrollment in E-trial.
研究组 & 干预措施
Control and/or Onartuzumab treatment
Participants will receive treatment with either the control treatment (erlotinib, bevacizumab) and/or onartuzumab-based study treatment (as during their P-trial) until progression of disease, unacceptable treatment related toxicity, withdrawal of consent, or death (whichever occurs first). All participants will continue on the same dose and schedule of control treatment as specified in their respective P-trial. The dose of onartuzumab will be calculated based on the participant's weight at the screening visit for the E-trial.
干预措施: Onartuzumab (Drug)
Control and/or Onartuzumab treatment
Participants will receive treatment with either the control treatment (erlotinib, bevacizumab) and/or onartuzumab-based study treatment (as during their P-trial) until progression of disease, unacceptable treatment related toxicity, withdrawal of consent, or death (whichever occurs first). All participants will continue on the same dose and schedule of control treatment as specified in their respective P-trial. The dose of onartuzumab will be calculated based on the participant's weight at the screening visit for the E-trial.
干预措施: Bevacizumab (Drug)
Control and/or Onartuzumab treatment
Participants will receive treatment with either the control treatment (erlotinib, bevacizumab) and/or onartuzumab-based study treatment (as during their P-trial) until progression of disease, unacceptable treatment related toxicity, withdrawal of consent, or death (whichever occurs first). All participants will continue on the same dose and schedule of control treatment as specified in their respective P-trial. The dose of onartuzumab will be calculated based on the participant's weight at the screening visit for the E-trial.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab
时间窗: Baseline through the end of trial (approximately 3 years)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
次要结局
未报告次要终点