NCT00504296已完成1 期
A Phase I Clinical and Pharmacokinetic Study of SB939 in Patients With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Recommended phase II dose
研究概览
简要总结
RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of SB939 in treating patients with locally advanced or metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- To determine the recommended phase II dose of oral SB939 in patients with solid tumors.
Secondary
- To determine the toxic effects of SB939 and its association with dose and pharmacokinetics.
- To assess the pharmacokinetic profile of SB939.
- To assess preliminary evidence of antitumor effects of SB939 in patients with measurable disease as documented by objective response.
- To establish proof-of-principle for SB939 effects on histone acetylation by evaluation of histone acetylation and other biomarkers in peripheral blood mononuclear cells (PBMCs) at all dose levels.
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
SB939
Experimental
干预措施: HDAC inhibitor SB939 (Drug)
SB939
Experimental
干预措施: immunoenzyme technique (Other)
SB939
Experimental
干预措施: immunohistochemistry staining method (Other)
SB939
Experimental
干预措施: immunologic technique (Other)
SB939
Experimental
干预措施: laboratory biomarker analysis (Other)
SB939
Experimental
干预措施: liquid chromatography (Other)
SB939
Experimental
干预措施: mass spectrometry (Other)
SB939
Experimental
干预措施: pharmacological study (Other)
结局指标
主要结局
Recommended phase II dose
时间窗: Each dose level
Assess for safety, tolerability, toxicity profile and dose limiting toxicities
次要结局
- Safety(Each dose level)
- SB939 effects on histone H3 acetylation(Cycle 1 days 1 and 15)
- Pharmacokinetic profile(Cycle 1 day 1 and 15)
研究者
研究点 (2)
Loading locations...
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