NCT01104675已完成2 期
A Phase 2 Study of Oral ENMD-2076 Administered to Patients With Platinum Resistant Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Progression free survival rate
研究概览
简要总结
The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites to be added.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Have histologically documented diagnosis of ovarian, fallopian or peritoneal cancer that is platinum resistant.
- •Have a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institution lower limit of normal
- •Greater than or equal to 18 years of age
- •Have clinically acceptable laboratory screening results
- •Have an ECOG performance status of 0 or 1
- •Able to tolerate oral medications
排除标准
- •Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); require two or more antihypertensive medications to control hypertension (including ACE inhibitors, beta blockers, calcium channel blockers, or diuretics)
- •Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec
- •Have active, acute, or chronic clinically significant infections or bleeding
- •Have persistent 2+ protein by urinalysis or a history of nephrotic syndrome
研究组 & 干预措施
ENMD-2076 treatment
Experimental
干预措施: ENMD-2076 (Drug)
结局指标
主要结局
Progression free survival rate
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (6)
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