A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients With Recurrent High-Grade Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 12
- 主要终点
- Objective Response Rate (ORR) (Arms 1 and 3)
研究概览
简要总结
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.
详细描述
See above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •≥ 18 years old
- •GBM and GBM variants, WHO Grade III anaplastic glioma diagnosis confirmed
- •Radiologically confirmed recurrent and bi-dimensionally measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria
- •Neurologically stable
- •For bevacizumab-refractory patients, radiologic demonstration of tumor progression during bevacizumab therapy
- •Karnofsky performance status (KPS) ≥ 80
- •Expected survival of at least 3 months
排除标准
- •More than three relapses
- •Previous ANG1005/GRN1005 treatment
- •Radiotherapy within 3 months.
- •Therapy with bevacizumab within 4 weeks prior to Day 1 of treatment for recurrent WHO grade III anaplastic glioma patients (Arm 3)
- •Evidence of significant intracranial hemorrhage
- •Previous taxane treatment
- •Prior therapy with bevacizumab for bevacizumab-naïve patients (Arm 1)
- •NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy
- •Inadequate bone marrow reserve
- •Any evidence of severe or uncontrolled diseases
- •Participants with the presence of an infection including abscess or fistulae, or known infection with hepatitis C or B or HIV
- •Known severe hypersensitivity or allergy to paclitaxel or any of its components
研究组 & 干预措施
Arm 1
ANG1005 administered to bevacizumab-naive recurrent GBM participants
干预措施: ANG1005 (Drug)
Arm 2
ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants
干预措施: ANG1005 (Drug)
Arm 2
ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants
干预措施: Bevacizumab (Drug)
Arm 3
ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants
干预措施: ANG1005 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) (Arms 1 and 3)
时间窗: Upon enrollment through end of study period (1 year after last patient is enrolled)
To determine the radiologic ORR in bevacizumab-naïve recurrent Glioblastoma multiforme (GBM) patients (Arm 1)and in recurrent anaplastic glioma World Health Organization (WHO) Grade III patients (Arm 3)
PFS3 (Arm 2)
时间窗: Upon enrollment through end of study period (1 year after last patient is enrolled)
To determine the progression-free survival at 3 months (PFS3) in bevacizumab-refractory recurrent GBM patients (Arm 2)
次要结局
- ORR in Arm 2(Upon enrollment through end of study period (1 year after last patient is enrolled))
- PFS at 3, 6 and 12 months(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Median PFS(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Duration of response(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Overall survival(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Safety and tolerability(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Plasma Pharmacokinetics of ANG1005 (Half-life [T1/2], Maximum Concentration [Cmax], Area Under the Curve [AUC])(At 0 h (pre-dose), at the end of infusion, at 2 and 4 hours post-dose on Day 1 of treatment cycles 1 and 3 (Week 1 and Week 9))