A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Progression-Free Survival at 6 Months (PFS-6)
研究概览
简要总结
The purpose of this study is to evaluate both enzastaurin and bevacizumab in the treatment of recurrent malignant gliomas.
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
- •Participant must be at least 18 years old
- •Participant must have been diagnosed with a recurrent brain tumor by magnetic resonance imaging (MRI) scan
- •Participant must be willing to practice adequate contraception
- •Participant must be able to swallow the enzastaurin tablets whole and receive bevacizumab intravenously
- •Participant must agree to use the study drug only as instructed by your study doctor and staff.
排除标准
- •Women who are pregnant or breastfeeding
- •Participants who have significant heart, liver, kidney, or psychiatric disease
- •Participants who have an active infection
- •Participants who have any recent bleeding in the brain
- •Participants who are taking any anti-coagulation or anti-platelet medication [including aspirin, non-steroidal anti-inflammatories, Cyclooxygenase-2 (COX-2) inhibitors]
研究组 & 干预措施
Enzastaurin + Bevacizumab
干预措施: enzastaurin (Drug)
Enzastaurin + Bevacizumab
干预措施: bevacizumab (Drug)
Enzastaurin + Bevacizumab
干预措施: Enzyme-inducing antiepileptic drugs (EIAED) (Drug)
Enzastaurin + Bevacizumab
干预措施: Non-enzyme inducing antiepileptic drugs (NEIAED) (Drug)
结局指标
主要结局
Progression-Free Survival at 6 Months (PFS-6)
时间窗: Registration to 6 months
Data presented are the percentage of participants without progressive disease (PD) or death from any cause 6 months after registration. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Time to Progressive Disease (PD)
时间窗: Registration to PD, death or date of last contact up to 66.56 months
Defined as the time from registration to PD, death or date of last contact. PD was a 25% increase in the sum of products of all measurable lesions (or 2 largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). Participants who had no PD or death at the time of the data inclusion cutoff, time to PD was censored at their last tumor assessment prior to the cutoff date.
Number of Participants With Adverse Events (AEs) or Deaths (Safety)
时间窗: Registration to study completion up to 67.56 months
Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
次要结局
- Change From Baseline in Health-Related Quality of Life (HRQoL) Subscales(Baseline, Cycles 1-12 (4-week cycles))
- Overall Response Rate (ORR)(Registration to date of objective PD or death up to 66.56 months)
- To Evaluate Tumor Markers and Genes(Baseline and every cycle (4-week cycles))