A Phase II Study of the c-MET RTK Inhibitor XL880 in Subjects With Papillary Renal-Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0
研究概览
简要总结
This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.
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
- •Histologically confirmed diagnosis of PRC with metastatic disease or bilateral multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance status of </=
- •Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.
排除标准
- •Radiation to >/=25% of bone marrow within 14 days of GSK1363089, more than 1 prior anti-cancer therapy, received prior treatment with a c-met inhibitor, brain metastases,
- •Any uncontrolled intercurrent illness,
- •Pregnant or breastfeeding,
- •HIV positive
研究组 & 干预措施
5/9 dosing
240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days.
干预措施: foretinib (formerly GSK1363089 or XL880) (Drug)
daily dosing
80 mg foretinib on a daily dosing regimen
干预措施: foretinib (formerly GSK1363089 or XL880) (Drug)
结局指标
主要结局
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0
时间窗: At the end of forth year
Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator's assessment of the target and non target lesions.
次要结局
- Overall Survival(Up to 4 years)
- Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case)(Up to 4 years)
- Disease Stabilization Rate Over Period(Up to 4 years)
- Duration of Response (DOR)(Up to 4 years)
- Duration of Stable Disease (SD)(Up to 4 years)
- Progression Free Survival (PFS)(At the end of forth year)
- Time to Response (TTR) Over Period(Up to 4 years)
- Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period(Up to 4 years)
- Number of Participants With Adverse Events, Serious Adverse Events, and Deaths(Up to 4 years)