NCT00493818终止1 期
An Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the AKT Inhibitor GSK690693 Given on Various Schedules in Subjects With Solid Tumors or Lymphoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- To determine the maximum tolerated dose of GSK690693 given weekly or twice weekly over 1 - 4 hours.
研究概览
简要总结
This study is a first time in human, Phase I, open-label study to determine recommended doses and schedules, based on maximum tolerated doses and biologically active doses, for the AKT inhibitor GSK690693.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to standard therapies or for which there is no approved therapy
- •Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
排除标准
- •Prior anti-cancer therapy within the prior 28 days.
- •History of diabetes.
- •Coronary artery disease/myocardial infarction, acute coronary syndromes within the past 6 months.
- •Use of theophylline and warfarin within 14 days prior to the first dose of study drug.
- •Current use of oral corticosteroids (note: Inhaled corticosteroids are permitted.)
- •Participation in an investigational study within the prior 28 days.
- •Pregnant or breast-feeding.
结局指标
主要结局
To determine the maximum tolerated dose of GSK690693 given weekly or twice weekly over 1 - 4 hours.
时间窗: given weekly or twice weekly over 1 - 4 hours
次要结局
- 12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs(4, 8, 10, 12, 14, 24hrs)
- Urinalysis samples while the patient is hospitalized(while the patient is hospitalized)
- Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion.(draws before, during, and after the infusion)
- Blood pressure and heart rate every 8 hours.(every 8 hours.)
研究者
研究点 (4)
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