NCT00127140已完成1 期
A Phase I Clinical Study of MK0683 in Patients With Malignant Lymphoma
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
- 10
- 主要终点
- Number of participants Experiencing Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral vorinostat in patients with malignant lymphoma.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy
排除标准
- •Patients with history of chemotherapy, antibody therapy, radiotherapy, during the previous 4 weeks (6 months for radioisotope-labeled antibody)
- •Any uncontrolled concomitant illness
- •Are pregnant or breast-feeding
- •Serious drug or food allergy
研究组 & 干预措施
Vorinostat
Experimental
Participants received (Cycle 1) once-daily vorinostat at assigned dose (100 or 200 mg) on Days 1 and 17 and twice-daily on Days 3-16. Thereafter, participants remaining on study received the same dose level therapy twice-daily for 14 consecutive days followed by 7 days of rest.
干预措施: vorinostat (Drug)
结局指标
主要结局
Number of participants Experiencing Dose-Limiting Toxicities (DLTs)
时间窗: Up to 21 days
次要结局
- Area Under the Curve (AUC) of Vorinostat After Single Oral Dosing(Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose on Days 1 and 17)
研究者
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