A Phase I Dose Finding Study of the Pan-DAC Inhibitor Panobinostat (LBH589) in Combination With Etoposide and Cisplatin in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer - An ICORG In-House Study
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Response rates and toxicity at MTD and RD
研究概览
简要总结
RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panobinostat together with etoposide and cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when given together with etoposide and cisplatin as first-line therapy in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose, the recommended dose, and the activity of panobinostat when given in combination with etoposide and cisplatin to patients with extensive-stage small cell lung cancer.
Secondary
- To estimate the time-to-progression, the duration of response, and disease stabilization in these patients.
- To estimate the overall survival of these patients.
- To determine the pharmacokinetic profile of panobinostat in combination with etoposide and cisplatin.
- To assess the overall safety profile of panobinostat in these patients.
- To determine the adverse events in these patients treated with this regimen.
- To assess the quality of life of these patients.
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
Cisplatin, Etoposide & Panobinostat
干预措施: cisplatin (Drug)
Cisplatin, Etoposide & Panobinostat
干预措施: etoposide phosphate (Drug)
Cisplatin, Etoposide & Panobinostat
干预措施: panobinostat (Drug)
Cisplatin, Etoposide & Panobinostat
干预措施: laboratory biomarker analysis (Other)
Cisplatin, Etoposide & Panobinostat
干预措施: pharmacological study (Other)
结局指标
主要结局
Response rates and toxicity at MTD and RD
Objective response rate according to RECIST criteria
Maximum-tolerated dose (MTD) and recommended dose (RD)
次要结局
- Time to progression according to RECIST criteria
- Duration of response or disease stabilization according to RECIST criteria
- Overall survival according to RECIST criteria
- Effect of the combination regimen on drug pharmacokinetics
- Adverse events
- Quality of life evaluated by EQ-5D (Euro QoL)