NCT00373490已完成1 期
MK0683 Phase1 Clinical Study - Solid Tumor -
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
- 16
- 主要终点
- Number of Participants With a Dose Limiting Toxicity (DLT)
研究概览
简要总结
This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically diagnosed solid tumor in whom no standard therapy is available or the malignancy is refractory to standard therapy
排除标准
- •Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks
- •Any uncontrolled concomitant illness
- •Pregnant or breast-feeding
- •Serious drug or food allergy
研究组 & 干预措施
Vorinostat 600 mg
Experimental
600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.
干预措施: Vorinostat (Drug)
Vorinostat 400 mg
Experimental
400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
干预措施: Vorinostat (Drug)
结局指标
主要结局
Number of Participants With a Dose Limiting Toxicity (DLT)
时间窗: 21 Days (first cycle)
Dose Limiting Toxicity = Drug-related side effects that are serious enough to prevent an increase in dose or level of that treatment
次要结局
- Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg)(Day 1 (600 mg and 400 mg))
- Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg)(Day 3 (600 mg))
- Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg)(Day 1 (600 mg and 400 mg))
- Maximum Concentration (Cmax) at Day 3 (600 mg)(Day 3 (600 mg))
- Maximum Concentration (Cmax) at Day 21 (400 mg)(Day 21 (400 mg))
- Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg)(Day 21 (400 mg))
研究者
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