NCT01302808已完成1 期
A Phase I/II Study of Erlotinib and Romidepsin in Advanced Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD)
研究概览
简要总结
RATIONALE: Romidepsin and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I/II trial is studying the side effects and best dose of romidepsin when given together with erlotinib hydrochloride and to see how well they work in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To characterize the toxicity and determine the maximum-tolerated dose (MTD) of erlotinib hydrochloride plus romidepsin. (Phase I)
- To obtain preliminary data regarding efficacy, including response rate and progression-free survival. (Phase II)
Secondary
- To characterize the pharmacokinetic profile of romidepsin in combination with erlotinib hydrochloride.
- To evaluate the impact of erlotinib hydrochloride on the biologic activity of romidepsin by analyzing peripheral blood mononuclear cell (PBMC) histone acetylation status and histone acetylase activity. (Exploratory)
- To evaluate the effect of romidepsin and erlotinib hydrochloride on components of the EGFR (epidermal growth factor receptor)-signaling pathway in skin biopsies, particularly downstream mediators such as MAPK (mitogen-activated protein kinase). (Exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD)
时间窗: 12 months
Dose limiting toxicities per Protocol definition using (CTCAE), Version 3.0
次要结局
- Area Under the Concentration-time Curve (AUC0 t) of Romidepsin in Combination With Erlotinib(0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Days 1 and 8)
研究者
David E Gerber
Professor of Medicine
University of Texas Southwestern Medical Center
研究点 (2)
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