GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases (GRABM-B)
2016年7月11日 更新者：Angiochem Inc
A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
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).
研究概览
详细说明
Please see Brief Summary section.
研究类型
介入性
注册 (实际的)
85
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Harvey、Illinois、美国、60426
- Ingalls Memorial Hospital
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Maryland
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Rockville、Maryland、美国、20892
- NCI
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Key Inclusion Criteria:
- 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
- KPS ≥ 70%
- Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose
Key Exclusion Criteria:
- NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known leptomeningeal disease
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：GRN1005
GRN1005 alone in HER2- MBC patients with brain mets.
18F-FLT may also be administered to this arm (if patient enrolled at NCI)
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550 mg/m2 IV every 3 weeks
其他名称：
5 mCi of 18F-FLT IV during Screening and during Cycle 1
其他名称：
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实验性的：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)
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550 mg/m2 IV every 3 weeks
其他名称：
5 mCi of 18F-FLT IV during Screening and during Cycle 1
其他名称：
2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Intra-cranial objective response rate in breast cancer patients with brain metastasis
大体时间：Upon enrollment through end of study period (1 year after last patient is enrolled)
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Upon enrollment through end of study period (1 year after last patient is enrolled)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Number of patients with adverse events as a measure of safety and tolerability of GRN1005 alone or in combination with Trastuzumab
大体时间：Upon enrollment through end of study period (1 year after last patient is enrolled)
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Upon enrollment through end of study period (1 year after last patient is enrolled)
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Intra-cranial objective response duration
大体时间：Upon enrollment through end of study period (1 year after last patient is enrolled)
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Upon enrollment through end of study period (1 year after last patient is enrolled)
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3-month intra-cranial progression-free survival
大体时间：Upon enrollment through end of study period (1 year after last patient is enrolled)
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Upon enrollment through end of study period (1 year after last patient is enrolled)
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Six month overall survival (OS)
大体时间：Upon enrollment through end of study period (1 year after last patient is enrolled)
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Upon enrollment through end of study period (1 year after last patient is enrolled)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Susan Bates, MD、National Cancer Institute (NCI)
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年10月1日
初级完成 (实际的)
2015年6月1日
研究完成 (实际的)
2015年10月1日
研究注册日期
首次提交
2011年11月16日
首先提交符合 QC 标准的
2011年11月23日
首次发布 (估计)
2011年11月29日
研究记录更新
最后更新发布 (估计)
2016年7月13日
上次提交的符合 QC 标准的更新
2016年7月11日
最后验证
2016年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
GRN1005的临床试验
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Angiochem Inc终止