A Phase I/II Trial of Temozolomide and ABT-888 in Subjects With Newly Diagnosed Glioblastoma Multiforme
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 11
- 主要终点
- Overall survival (Phase II)
研究概览
简要总结
RATIONALE: ABT-888 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with radiation therapy and temozolomide may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ABT-888 when given together with radiation therapy and temozolomide and to see how well it works in treating patients with newly diagnosed glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose (MTD) of ABT-888 when administered in combination with radiotherapy and temozolomide in patients with newly diagnosed glioblastoma multiforme. (Phase I)
- To estimate the overall survival of patients treated with ABT-888 when administered at the MTD in combination with radiotherapy and temozolomide. (Phase II)
Secondary
- To assess the toxicity associated with this regimen. (Phase I)
- To assess and describe the pharmacokinetics of ABT-888. (Phase I)
- To estimate the frequency of toxicity associated with this regimen. (Phase II)
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation
干预措施: gene expression analysis (Genetic)
Dose Escalation
干预措施: temozolomide (Drug)
Dose Escalation
干预措施: veliparib (Drug)
Dose Escalation
干预措施: DNA methylation analysis (Genetic)
Dose Escalation
干预措施: mutation analysis (Genetic)
Dose Escalation
干预措施: proteomic profiling (Genetic)
Dose Escalation
干预措施: high performance liquid chromatography (Other)
Dose Escalation
干预措施: immunoenzyme technique (Other)
Dose Escalation
干预措施: laboratory biomarker analysis (Other)
Dose Escalation
干预措施: mass spectrometry (Other)
Dose Escalation
干预措施: pharmacogenomic studies (Other)
Dose Escalation
干预措施: pharmacological study (Other)
Dose Escalation
干预措施: adjuvant therapy (Procedure)
Dose Escalation
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Overall survival (Phase II)
时间窗: continous
Maximum tolerated dose of ABT-888 (Phase I)
时间窗: continous
次要结局
- Frequency of toxicity (Phase II)(continous)
- Toxicity (Phase I)(continous)
- Pharmacokinetics of ABT-888 (Phase I)(continous)