Phase 2 Study of Efficacy and Safety of Trabectedin in Subjects With Advanced Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 主要终点
- Number of patients with objective response
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian 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. Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Trabectedin at a starting dose of 0.58 mg/m2 will be given to patients intravenously (i.v). as a 3-hour infusion every week for 3 weeks (on Days 1, 8, and 15) of a 4 week cycle via a central venous catheter (also referred to as a "central line" which is a tube ie, "catheter" placed into a large vein). All patients will receive dexamethasone 10 mg i.v. 30 minutes prior to each trabectedin infusion. Patients may receive multiple cycles of trabectedin in the absence of disease progression.
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 epithelial ovarian cancer
- •Progression or recurrence during or after platinum-containing regimen
- •At least one measureable tumor lesion
- •Adequate bone marrow, hepatic and renal function
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
排除标准
- •Known hypersensitivity to any components of the i.v. formulation of trabectedin or dexamethasone
- •Pregnant or lactating women
- •Known metastases (spread) of cancer to the central nervous system
- •History of another neoplastic disease unless in remission for five years or more.
研究组 & 干预措施
Trabectedin
Trabectedin 0.58 mg/m2 administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.
干预措施: Trabectedin (Drug)
Trabectedin
Trabectedin 0.58 mg/m2 administered as a 3-hour intravenous infusion, Days 1, 8, and 15 every 28 days for up to approximately 3 years in the absence of disease progression. Dexamethasone 10 mg administered intravenously 30 minutes prior to each trabectedin infusion.
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
- The number of patients with an unbiased objective response(Up to approximately 3 years)
- Progression-free survival(Up to approximately 3 years)
- Time to progression(Up to approximately 3 years)
- Overall survival(Up to approximately 3 years)
- Duration of response(Up to approximately 3 years)
- Duration of stable disease(Up to approximately 3 years)
- Cancer antigen 125 (CA125) response(Up to approximately 3 years)
- The number of patients with adverse events(Up to approximately 3 years)