NCT02048059已完成2 期
A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 19
- 主要终点
- Intracranial objective response rate (iORR)
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 breast cancer patients with recurrent brain metastases.
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
- •≥ 18 years old
- •Breast cancer
- •Recurrent brain metastases from breast cancer
- •At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
- •Neurologically stable
- •Karnofsky Performance Status (KPS) score ≥ 70
- •Adequate hematology and serum chemistry laboratory test results
- •Expected survival of ≥ 3 months
排除标准
- •Prior treatment with ANG1005/GRN1005
- •Evidence of symptomatic intracranial hemorrhage
- •Pregnancy or lactation
- •Inadequate bone marrow reserve
- •Any evidence of severe or uncontrolled diseases
- •Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
- •History of interstitial lung disease or evidence of clinically significant interstitial lung disease
- •Severe cardiac conduction disturbance
- •Central nervous system (CNS) disease requiring immediate neurosurgery intervention
- •Known severe hypersensitivity or allergy to paclitaxel or any of its components
研究组 & 干预措施
ANG1005
Experimental
Participants received ANG1005 intravenously (IV) at a dose of 600 mg/m^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated.
干预措施: ANG1005 (Drug)
结局指标
主要结局
Intracranial objective response rate (iORR)
时间窗: Upon enrollment through end of study period (1 year after last patient is enrolled)
次要结局
- Duration of intracranial objective response(Upon enrollment through end of study period (1 year after last patient is enrolled))
- 6-month overall survival (OS) rate(Upon enrollment through end of study period (1 year after last patient is enrolled)
- Extracranial objective response rate (eORR) and duration of response(Upon enrollment through end of study period (1 year after last patient is enrolled)
- Number of Patients with adverse events(Upon enrollment through end of study period (1 year after last patient is enrolled)
- Plasma pharmacokinetics of ANG1005(On Day 1 of Cycles 1 and 3)
- Median intracranial progression-free survival (PFS)(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Intracranial PFS rates at 3, 6 and 12 months(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Intracranial clinical benefit rate (iCBR) at 3 and 6 months(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Potential immunogenicity of ANG1005(Upon enrollment through end of study period (1 year after last patient is enrolled))
研究者
研究点 (19)
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