Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Efficacy-Finding part: Progression-free survival
研究概览
简要总结
This open-label, multicenter study will evaluate the safety and efficacy of RO5323441 in combination with Avastin (bevacizumab) in patients with recurrent glioblastoma. In the dose-finding part, patients will receive intravenous escalating doses of RO5323441 in combination with 10 mg/kg Avastin once every two weeks. In the efficacy-finding part, patients will be randomized to receive the established dose (from the dose-finding part) of RO5323441 plus Avastin or Avastin alone. Patients in the dose-finding part may continue treatment with RO5323441 and Avastin on the study until evidence of progressive disease or unacceptable adverse events happen. In the efficacy-finding part, patients will receive study treatment until disease progression or death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult patients, >/=18 years of age
- •Histologically confirmed glioblastoma
- •Radiographic demonstration of disease progression by Response Assessment in Neurooncology (RANO) criteria following prior therapy
- •Availability of at least 1 formalin-fixed paraffin-embedded tumor tissue sample
- •If receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids
- •Prior standard radiotherapy for glioblastoma
- •Karnofsky Performance status >/=70
- •Over 4 weeks since prior surgical resection
- •Over 12 weeks from radiotherapy
- •Over 4 weeks from anticancer agents
排除标准
- •Patients had second or later glioblastoma relapse
- •Patients received more than one systemic treatment regimen for glioblastoma
- •Patients have secondary glioblastoma
- •Prior treatment with Avastin
- •Patients unable to undergo Magnetic Resonance Imaging (MRI)
研究组 & 干预措施
1
干预措施: RO5323441 + bevacizumab [Avastin] (Drug)
2
干预措施: bevacizumab [Avastin] (Drug)
结局指标
主要结局
Efficacy-Finding part: Progression-free survival
时间窗: From baseline to disease progression or death (>12 months)
Dose-Finding Part: Dose limiting toxicity
时间窗: Day 28
次要结局
- Dose-Finding part: Pharmacokinetics of RO5323441 and Avastin when combined(From baseline to disease progression or death (>12 months))
- Dose-Finding part: Safety (incidence of adverse events)(From baseline to disease progression or death (>12 months))
- Dose-Finding part: Efficacy (tumor response according to Response Assessment in Neurooncology (RANO) criteria(From baseline to disease progression or death (>12 months))
- Dose-Finding part: Glioblastoma biomarker(From baseline to disease progression or death (>12 months))
- Efficacy-Finding part: Overall Response Rate(From baseline to disease progression or death (>12 months))
- Efficacy-Finding part: Disease Control Rate(From baseline to disease progression or death (>12 months))
- Efficacy-Finding part: Duration of Response(From baseline to disease progression or death (>12 months))
- Efficacy-Finding part: Progression-free survival(From baseline to disease progression or death (>12 months))
- Efficacy-Finding part: Overall Survival(From baseline to disease progression or death (>12 months))
- Efficacy-Finding part: Safety (incidence of adverse events)(From baseline to disease progression or death (>12 months))
- Efficacy-Finding part: Glioblastoma biomarker(From baseline to disease progression or death (>12 months))
- Efficacy-Finding part: Pharmacokinetics (serum levels) of RO5323441 and Avastin when combined(From baseline to disease progression or death (>12 months))