EUCTR2004-005181-20-HU进行中（未招募）不适用
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
适应症
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
- 810
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
- •- Histologically confirmed diagnosis of epithelial ovarian, primary fallopian or primary peritoneal cancer.
- •- No more than one prior taxane/platinum-based combination chemotherapy regimen at the initial platinum dose of carboplatin AUC 5-6 or cisplatin 75mg/m2
- •- Taxane/platinum refractory/resistant patients must present with either measurable (by RECIST criteria) or non-measurable (CA-125 by Rustin criteria) progressive disease
- •- Left ventricular ejection fraction (LVEF) >/= 50% by MUGA or 2-D echocardiography
- •- Age > 18 years.
- •- WHO performance status of 0, 1, or 2.
- •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
- •- Patients with CA-125-only disease
- •- Unresolved bowel obstruction
- •- Prior administration of and/or known hypersensitivity to: epothilones, anthracyclines and/or pegylated liposomal doxorubicin
- •- Any peripheral neuropathy > CTC grade 1
- •- Unresolved diarrhea of any grade within last 7 days prior to start of treatment.
- •- Presenting with leptomeningeal involvement
- •- Within 3 weeks of receiving any prior chemotherapy or radiotherapy or who are planning to receive either while participating in the study
- •- Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease
- •- History of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or cervical cancer in situ
- •- Receiving hematopoietic growth factors (except erythropoietin)
- •- Concomitant administration of Coumadin® or other agents containing warfarin
- •- Concomitant administration of any drug/agent known to cause, or increase the severity of, diarrhea
- •Concomitant administration of any drug/agent known to interact negatively with doxorubicin or pegylated liposomal doxorubicin
研究者
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进行中（未招募）
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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 canceradvanced epithelial ovarian cancerMedDRA version: 14.1Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2004-005181-20-ITOVARTIS FARMA810
进行中（未招募）
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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 cancerApproximately 75% of women with ovarian cancer present advanced disease. Survival is highly dependent on the stage of disease at the initiation of treatment. Recommended first-line therapy is a combination of platinum drug and paclitaxel. Patients who progress during primary therapy or within 6 months after are considered platinum refractory/resistant. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeksEUCTR2004-005181-20-GRovartis Pharma Services AG
进行中（未招募）
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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 cancerEUCTR2004-005181-20-ESovartis Farmacéutica, S.A
进行中（未招募）
不适用
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 cancerApproximately 75% of women with ovarian cancer present advanced disease. Survival is highly dependent on the stage of disease at the initiation of treatment. Recommended first-line therapy is a combination of platinum drug and paclitaxel. Patients who progress during primary therapy or within 6 months after are considered platinum refractory/resistant. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeksEUCTR2004-005181-20-DKovartis Pharma Services AG810
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 cancerNL-OMON31592ovartis8