NCT01965080已完成2 期
Phase 2 Study of Exemestane in Advanced and Recurrent Endometrial Carcinoma
Nordic Society of Gynaecological Oncology - Clinical Trials Unit1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2004年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
A phase II study of Exemestane in Advanced or recurrent endometrial carcinoma
Hypothesis: Treatment With Exemestane can give a response rate of at least 30%
详细描述
Patients With Advanced or recurrent endometrial cancer of endometrioid type were treated With Exemestane tablets 25 mg daily.
Patients were grouped according to estrogen receptor status.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Advanced or recurrent endometrial cancer not considered for treatment modalities apart from hormonal treatment
- •Endometrioid histology
- •Age above 18 years
- •Post menopausal status
- •Performance status 0-2
- •Informed consent
排除标准
- •Congestive heart disease grade III.IV
- •History of thromboembolic signs
- •Other primary hormonal therapy
- •Patients With symptomatic brain metastasis
- •Severe hepatic or renal impairment
- •Pregnancy, lactation or child bearing potential without adequate contraception
研究组 & 干预措施
Exemestane
Experimental
Exemestane 25 mg daily
干预措施: Exemestane (Drug)
结局指标
主要结局
Response rate
时间窗: 6 months
Objective response rate within 6 months of treatment
次要结局
- Progression free survival(2 years)
研究者
研究点 (1)
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