NL-OMON31592已完成3 期
A randomized, parallel group, open-label, active controlled, multicenter Phase III trial of Patupilone (EPO906) versus pegylated liposomal doxorubicin (Doxil/Caelyx) in taxane/platinum refractory/resistant patients with recurrent epithelial ovarian, primary fallopian or primary peritoneal cancer - Phase III study with Patupilone vs Caelyx® in ovarian carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Histologically confirmed ovarium carcinoom.
- •2. Resistant / refractory to prior platinum-based chemotherapy (up to three prior regimens)
- •3. Measurable progressive disease (RECIST) or progression based on non-measurable lesions and CA-125.
- •4. WHO performance status * 2.
- •5. Left ventricular ejection fraction (LVEF) * 50%
- •6. Hematology: WBC > 3.0 x 109/L; ANC * 1.5 x 109/L; Hb * 10.0 g/dL; Platelet count * 100 x 109/L
- •7. Blood chemistry: Normal total bilirubin; AST/ALT * 2.5 x ULN; serum creatinine < 1.5 x ULN; Alkaline Phosphatase < 5 x ULN
- •8. Negative serum pregnancy test
- •9. Sexually active female patients must either be surgically sterilized, post-menopausal or practicing adequate contraceptive methods
排除标准
- •1. Patients with CA-125-only disease.
- •2. Unresolved bowel obstruction.
- •3. Prior administration of and/or known hypersensitivity to: epothilones, anthracyclines and/or pegylated liposomal doxorubicin.
- •4. Peripheral neuropathy > CTC grade 1.
- •5. Unresolved diarrhea of any grade within last 7 days prior to start of treatment.
- •6. Presenting with leptomeningeal involvement.
- •7. Colostomy.
- •8. Underlying uncontrolled medical disease(s) including unstable cardiac or coronary artery disease
研究者
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