NCT02532868终止1 期
A Phase I Dose Escalation Study of MK0457 Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a 24-Hour Continuous Infusion Given Every 21 Days in Patients With Advanced Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 主要终点
- Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the oral formulation will also be assessed. The primary study hypothesis is that administration of MK-0457 is sufficiently safe and tolerated to permit further study.
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
- •Patients who are at least 18 years of age with recurrent or non-responsive solid tumors, or cancers for which standard therapy does not exist.
排除标准
- •Patients who have had treatment with any investigational therapy within the past 30 days.
- •Patients who have certain types of blood cancers such as leukemia or lymphoma.
- •Patients who have uncontrolled congestive heart failure (CHF), chest pains, or had a heart attack within the past 3 months, or have undergone bone marrow or stem cell transplantation.
- •Patient is pregnant or nursing.
研究组 & 干预措施
MK-0457
Experimental
Participants received MK-0457 at assigned dose as a continuous intravenous infusion (CIV) over 24 hours; one group of participants also received MK-0457 100 mg capsules, orally, prior to the CIV.
干预措施: MK-0457 (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
- Change in standard uptake value (SUV) in fluorodeoxyglucose positron emission tomography (FDG-PET) scans(Predose, and at end of Cycles 2 and 6 (up to approximately 4 months))
- Overall Tumor Response Per Response Evaluation Criteria in Solid Tumors (RECIST)(Pre-dose through post-study visit (up to 3 years))
研究者
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