Study of Sorafenib + TH-302: Phase I in Advanced Renal Cell Carcinoma (RCC) and Advanced Hepatocellular Carcinoma (HCC) and Phase II in 1st Line Advanced HCC
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- MTD of sorafenib tosylate and TH-302 (Phase I)
研究概览
简要总结
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth by blocking blood flow to the tumor. Drugs used in chemotherapy, such as hypoxia-activated prodrug TH-302, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib tosylate together with hypoxia-activated prodrug TH-302 may kill more tumor cells.
PURPOSE: This phase I/II trial studies the side effects and best dose of giving sorafenib tosylate together with hypoxia-activated prodrug TH-302 and to see how well they work in treating patients with advanced kidney cancer or liver cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose (MTD) and recommended Phase II dosing (RP2D) for the combination of sorafenib tosylate and hypoxia-activated prodrug TH-302 (TH-302) in patients with hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC; non-HCC) advanced solid tumors. (Phase I)
- To evaluate the overall response rate (RR) determined based on modified RECIST criteria (Lencioni and Llovet 2010) in patients with advanced HCC receiving sorafenib tosylate with TH-302. (Phase II)
Secondary
- To characterize overall toxicity profile of sorafenib tosylate + TH-302 within patients with HCC and RCC (non-HCC) advanced solid tumors. (Phase I)
- To characterize the responses of sorafenib tosylate + TH-302 within patients with HCC and RCC (non-HCC) advanced solid tumors. (Phase I)
- To assess the adverse events (AEs) profile and safety profile of sorafenib tosylate in combination with TH-302 in patients with advanced HCC. (Phase II)
- To estimate the overall response rate based on standard RECIST criteria in the study population. (Phase II)
- To estimate the duration of response based on modified (standard) RECIST criteria in the study population. (Phase II)
- To estimate the progression free survival (PFS) in the study population. (Phase II)
- To estimate the overall survival (OS) in the study population. (Phase II)
- To estimate the alpha-fetoprotein (AFP) response rate (defined as > 20% decrease of AFP from baseline) in the study population. (Phase II)
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
sorafenib and TH-302
Patients will be administered sorafenib tablets to take twice daily by mouth, every day of each cycle. Patients will also be given TH-302 intravenously (IV) on days 8, 15 and 22 of each cycle. A cycle is 28 days.
干预措施: sorafenib tosylate (Drug)
sorafenib and TH-302
Patients will be administered sorafenib tablets to take twice daily by mouth, every day of each cycle. Patients will also be given TH-302 intravenously (IV) on days 8, 15 and 22 of each cycle. A cycle is 28 days.
干预措施: hypoxia-activated prodrug TH-302 (Drug)
结局指标
主要结局
MTD of sorafenib tosylate and TH-302 (Phase I)
时间窗: Up to 24 weeks
Overall response rate (Phase II)
时间窗: Up to 3 years
Number of dose-limiting toxicity incidents as assessed by CTCAE version 4.0 (Phase I)
时间窗: Up to 24 weeks
次要结局
- Adverse events as assessed by NCI CTCAE version 4.0 (Phase II)(Up to 3 years)
- Overall response rate based on standard RECIST criteria (Phase II)(Up to 3 years)
- OS (Phase II)(Up to 3 years)
- AFP response rate (Phase II)(Up to 3 years)
- Duration of response based on modified (standard) RECIST criteria (Phase II)(Up to 3 years)
- PFS (Phase II)(Up to 3 years)