A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Number of patients with objective response
研究概览
简要总结
The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.
详细描述
Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the Investigator conducting this study. Trabectedin 1.3 mg/m2 will be given every 21 days to patients intravenously (i.v). over a 3-hour period via a central venous catheter (referred to as a "central line") which is a tube (ie, catheter) placed into a large vein that is used to administer medications. Dexamethasone 4 mg will be given orally (p.o.) the day before trabectedin and dexamethasone 20 mg will be given i.v. 30 minutes before trabectedin. Dexamethasone 4 mg p.o. will be given for 2 days following trabectedin administration.
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
- •Diagnosis of advanced or metastatic endometrial carcinoma
- •Progressive disease after 1 cytotoxic chemotherapy regimen given for advanced/metastatic disease
- •At least one measureable tumor lesion
- •Adequate bone marrow, hepatic and renal function
- •Performance status ECOG 0 or 1
排除标准
- •Prior exposure to trabectedin
- •Known hypersensitivity to dexamethasone or to any of the components of trabectedin
- •Less than 4 weeks since last radiation therapy or since last dose of hormonal therapy, biological therapy, therapy with any investigational agent, or chemotherapy
- •History of another neoplastic disease unless in remission for more than 5 years
- •Known metastases (spread) of cancer to the central nervous system or other serious illness as specified in the protocol
- •Current pregnancy, lactation, or childbearing potential without adequate method of contraception.
研究组 & 干预措施
Trabectedin
Trabectedin 1.3 mg/m2 administered intravenously every 21 days. Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose.
干预措施: Trabectedin (Drug)
Trabectedin
Trabectedin 1.3 mg/m2 administered intravenously every 21 days. Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of patients with objective response
时间窗: Up to approximately 3 years
次要结局
- Overall survival (OS)(Up to approximately 3 years)
- The number of patients with adverse events(Up to approximately 3 years)
- Time to progression (TTP)(Up to approximately 3 years)
- Progression free survival (PFS),(Up to approximately 3 years)