Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Agennix
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose and Safety
研究概览
简要总结
This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.
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
- •Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
- •Life expectancy of at least 3 months
- •Measurable or evaluable disease
- •ECOG performance status of <= 2
- •Willingness and ability to give informed consent
排除标准
- •Women who are pregnant or breastfeeding
- •Other chemotherapy treatment less than 4 weeks prior to enrollment
- •Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment
- •Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
结局指标
主要结局
Maximum Tolerated Dose and Safety
时间窗: 3 weeks
次要结局
- Objective response rate(3 weeks)