A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Intra-cranial objective response rate in breast cancer patients with brain metastasis
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice.
In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).
详细描述
Please see Brief Summary section.
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
- •Age ≥ 18 years
- •Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR status must be known)
- •Brain metastasis from breast cancer with or without prior WBRT
- •At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0 cm in the longest diameter) by Gd-MRI of the brain < 14 days prior to first dose (Metastatic brain lesions previously treated with SRS may not be target or non-target lesions)
- •Patients must be neurologically stable: On stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose
- •Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose
排除标准
- •NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- •CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- •Known leptomeningeal disease
研究组 & 干预措施
GRN1005
GRN1005 alone in HER2- MBC patients with brain mets. 18F-FLT may also be administered to this arm (if patient enrolled at NCI)
干预措施: GRN1005 (Drug)
GRN1005
GRN1005 alone in HER2- MBC patients with brain mets. 18F-FLT may also be administered to this arm (if patient enrolled at NCI)
干预措施: 18F-FLT (Drug)
GRN1005 with trastuzumab
GRN1005 in combination with trastuzumab in MBC patients with brain mets 18F-FLT may also be administered to this arm (if patient enrolled at NCI)
干预措施: GRN1005 (Drug)
GRN1005 with trastuzumab
GRN1005 in combination with trastuzumab in MBC patients with brain mets 18F-FLT may also be administered to this arm (if patient enrolled at NCI)
干预措施: Trastuzumab (Drug)
GRN1005 with trastuzumab
GRN1005 in combination with trastuzumab in MBC patients with brain mets 18F-FLT may also be administered to this arm (if patient enrolled at NCI)
干预措施: 18F-FLT (Drug)
结局指标
主要结局
Intra-cranial objective response rate in breast cancer patients with brain metastasis
时间窗: Upon enrollment through end of study period (1 year after last patient is enrolled)
次要结局
- Number of patients with adverse events as a measure of safety and tolerability of GRN1005 alone or in combination with Trastuzumab(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Six month overall survival (OS)(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Intra-cranial objective response duration(Upon enrollment through end of study period (1 year after last patient is enrolled))
- 3-month intra-cranial progression-free survival(Upon enrollment through end of study period (1 year after last patient is enrolled))