A Phase II, Multi-center, Open-label Study Evaluating the Efficacy and Safety of GRN1005 in Non-Small Cell Lung Cancer Patients With Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) 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 non-small cell lung cancer (NSCLC).
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
- •Adult patients (≥ 18 years)
- •Histologically or cytologically-documented NSCLC (EGFR mutation status must be known)
- •Brain metastases from NSCLC, which:
- •have radiologically-progressed after WBRT or are present without prior WBRT
- •At least one radiologically-confirmed and measurable lesion (≥ 1.0 cm in the longest diameter) within14 days prior to the first dose of GRN1005 (Cycle 1, Day 1), as follows: an intra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by Gd-MRI, or an extra-cranial disease lesion (≥ 1.0 cm in the longest diameter) confirmed by MRI or CT scan with contrast Prior stereotactic radiosurgery (SRS) is allowed; however, metastatic brain lesions previously treated with SRS are not allowed as target or as non-target lesions.
- •Patients must be neurologically stable, defined as being 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 of GRN1005 (Cycle 1, Day 1).
- •Karnofsky Performance Score (KPS) ≥ 80%
- •Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose of GRN1005 (with the exception of local radiation therapy for palliation to extra-cranial sites, i.e., bone). All clinically significant toxicities must have resolved to ≤ NCI CTCAE v4.0 Grade 1.
排除标准
- •NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- •CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- •Known intra-cranial hemorrhage
- •Known leptomeningeal disease
研究组 & 干预措施
GRN1005 alone
GRN1005 alone
干预措施: GRN1005 (Drug)
结局指标
主要结局
Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis
时间窗: upon enrollment through end of study period (1 year after last patient is enrolled)
Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), \< 30% decrease but \<20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), \>= 20% (\>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR.
次要结局
- Duration of Overall Progression Free Survival(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Six Month Overall Survival(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Number of Patients With Adverse Events as a Measure of Safety and Tolerability(Upon enrollment through end of study period (1 year after last patient is enrolled))
- Duration of Overall Objective Response(Upon enrollment through end of study period (1 year after last patient is enrolled))