A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 主要终点
- Number and percentage of participants with adverse events
研究概览
简要总结
This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glioblastoma Multiforme (GBM)
- •70 or above on Karnofsky Performance Status
- •Adequate bone marrow function
- •Recurrent GBM per RANO criteria
- •Subjects must have confirmed EGFR amplification by central lab
排除标准
- •For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
- •For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
- •Allergies to temozolomide, dacarbazine, IgG containing agents
- •Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
- •Subjects that have had more than one disease recurrence
研究组 & 干预措施
Arm A
ABT-414 in combination with radiation and temozolomide
干预措施: ABT-414 (Drug)
Arm A
ABT-414 in combination with radiation and temozolomide
干预措施: Temozolomide (Drug)
Arm A
ABT-414 in combination with radiation and temozolomide
干预措施: Whole Brain Radiation (Radiation)
Arm B
ABT-414 in combination with temozolomide
干预措施: ABT-414 (Drug)
Arm B
ABT-414 in combination with temozolomide
干预措施: Temozolomide (Drug)
Arm C
ABT-414 monotherapy
干预措施: ABT-414 (Drug)
结局指标
主要结局
Number and percentage of participants with adverse events
时间窗: Every week for an expected average of 34 weeks
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Maximum concentration of ABT-414
时间窗: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Measurement of the maximum concentration of ABT- 414 in the blood
Number of Dose Limiting Toxicities
时间窗: Every week for an expected average of 34 weeks
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Minimum Concentration of ABT-414
时间窗: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Measurement of the minimum concentration of ABT-414 in the blood
Half-life of ABT-414
时间窗: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Measurement of the clearance of ABT-414
次要结局
- Overall Survival(Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or participant becomes lost to follow up, or study termination)
- Biomarker EGFR expression(At screening and post-study)
- Progression Free Survival(Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or the participant becomes lost to follow up, or study termination.)