A Phase II Study of Pazopanib in VEGF-TKI Refractory Metastatic Renal Cell Carcinoma (MRCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Confirmed Response Rate (Complete Response and Partial Response) as Assessed by RECIST 1.1 Criteria
研究概览
简要总结
RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well pazopanib hydrochloride works in treating patients with stage IV kidney cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the response rate (RR) associated with pazopanib (pazopanib hydrochloride) as 3rd-line therapy in metastatic renal cell carcinoma (mRCC) patients who have failed therapy with a distinct vascular endothelial growth factor (VEGF)-tyrosine kinase inhibitor (TKI).
SECONDARY OBJECTIVES:
I. To determine if baseline hepatocyte growth factor (HGF), endothelial selectin (E-selectin) and interleukin-6 (IL-6) are associated with progression-free survival (PFS).
II. To determine if pre-metastatic niche density in regional lymph nodes (LNs) is associated with PFS.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: pazopanib hydrochloride (Drug)
Arm I
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm I
Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: immunologic technique (Other)
结局指标
主要结局
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by RECIST 1.1 Criteria
时间窗: 1 year post treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Overall Response (OR) = CR + PR.
次要结局
- Overall Survival(1 year post treatment)
- Progression-free Survival(1 year post treatment)