A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Agennix
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determination of MTD and recommended dose for phase II trials
研究概览
简要总结
PURPOSE: This trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.
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.
RATIONALE: Intravenously administered platinum-based drugs are currently used in combination with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy treatment.
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
- •Locally advanced or medically inoperable NSCLC (stage II or III)
- •ECOG performance status score 0-2
- •Adequate bone marrow, liver, and pulmonary functions
- •Life expectancy > three months.
排除标准
- •Prior malignancy
- •Serious concurrent uncontrolled medical disorder.
- •Uncontrolled or significant cardiovascular disease
- •History of mastectomy
- •Pregnant or breast-feeding patients are not eligible
- •Prior radiotherapy to the primary tumor site or cytotoxic chemotherapy
研究组 & 干预措施
Satraplatin
Satraplatin
干预措施: Satraplatin (Drug)
结局指标
主要结局
Determination of MTD and recommended dose for phase II trials
时间窗: 30 days
次要结局
未报告次要终点