NCT03446495Unknown不适用
A Non-interventional, Multicenter Study of the Combination of Pegylated Liposomal Doxorubicin and Trabectedin in Routine Practice in Patients With Recurrent Partial-platinum Sensitive Ovarian Cancer
Suriya Yessentayeva9 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a Non-interventional, Multicenter study evaluating the efficacy and safety of the combination of pegylated liposomal doxorubicin and trabectedin in routine practice in patients with recurrent partial-platinum sensitive ovarian cancer, which is held in Kazakhstan.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Histologically proven epithelial ovarian cancer
- •Partially platinum sensitive relapsed ovarian cancer: platinum-free interval 6 -12 months
- •With 1-2 or more cycles on trabectedin treatment at the recommended dose of 1.1mg/m2 q3w 3hr infusion in combination of PLD at 30mg/ml with appropriate pre-medication
- •Prior treatment with 1 or more chemotherapy regimen
排除标准
- •Platinum resistant disease: PFI < 6 months (progression within six months after first-line platinum-based chemotherapy)
- •Unwilling or unable to have a central venous catheter
- •Patients with hepatic impairment (Patients with elevated bilirubin)
- •Patients with renal impairment (Patients with serum creatinine >1.5 mg/dL)
- •Patients with hematologic impairment (baseline neutrophil counts of less than 1,500 cells/mm3 and platelets count of less than 100,000 cells/mm3)
- •Patients with serious impaired cardiac function (patients with cardiac disease and with reduction of the QRS complex)
- •AIDS-related Kaposi's sarcoma
- •Lactation or pregnancy
研究组 & 干预措施
Trabectedin + PLD
Trabectedin + PLD according to SmPC
干预措施: Trabectedin + PLD (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Patient will be followed during 37 weeks
ORR will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST V 1.1).
次要结局
- Progression-Free Survival (PFS)(Patient will be followed during 37 weeks)
- Safety according to CTCAE v4.0(Patient will be followed during 37 weeks)
研究者
Suriya Yessentayeva
Chair
Scientific Medical Society, Kazakhstan
研究点 (9)
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