EUCTR2008-002668-32-LV进行中（未招募）不适用
An Open, Randomized, Multicenter Study in Patients with Recurrent Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficacy and Safety of paclitaxel (micellar) nanoparticles and paclitaxel(Cremophor® EL)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.
- •2.Patients relapsing > 6 months after end of first line or second line treatment including platinum based therapy. Prior therapy and duration of response will be documented in the CRF for descriptive analysis.
- •3.CA 125 >2 x upper normal limit (UNL) documented at two occasions, with more than one week interval, according to appendix I, patient groups A and B, measurable/non- measurable disease.
- •4.Age > 18 years
- •5.Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- •6.Life expectancy >12 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patient has peripheral neuropathy of grade = 2 per NCI- CTCAE version 3.0
- •2.Surgical procedure due to progressive disease within 4 weeks of any of the CA- 125 measurements
- •3.Patient receiving concurrent hormonal, immuno-, or radiotherapy. Treatment must have stopped for at least 4 weeks before start of drug treatment (Day 1 , Cycle 1).
- •4.Bowel obstruction at screening
研究者
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