NCT00523380已完成2 期
An Open-Label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients With Persistent or Progressive Disease After, or Relapse Within One Year of, Completion of Standard First Line Therapy
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
- 10
- 试验地点
- 1
- 主要终点
- Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.
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
- •Advanced epithelial Ovarian Cancer (stage IIB-IV)
- •Persistent or progressive disease after or relapse within one year of completion of first line therapy
- •Measurable or assessable disease
- •Eastern Cooperative Oncology Group status less than or equal to 2
排除标准
- •History of any other active malignancy
- •Signs of CNS metastasis
- •More than one prior chemotherapy regimen
- •Radiotherapy (bone) less than 4 weeks prior to start of treatment and radiotherapy (visceral) less than 8 weeks
- •First line chemotherapy completed at least 1 month prior to start of treatment
研究组 & 干预措施
A
Experimental
干预措施: caelyx (pegylated liposomal doxorubicin) (Drug)
A
Experimental
干预措施: recombinant interleukin-21 (Drug)
结局指标
主要结局
Efficacy of treatment assessed by overall response rate (RR). RR measured and recorded using imaging techniques, CA-125 blood samples and pelvic examination.
时间窗: after max. 6 treatment cycles
次要结局
- IL-21 antibody formation(For the duration of the trial)
- Progression free survival(For the duration of the trial)
- Patient reported outcomes(For the duration of the trial)
- Biomarker assessments CA-125(For the duration of the trial)
- Pharmacokinetics(Initially)
研究者
研究点 (1)
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