EUCTR2004-005181-20-DK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.
- •- Resistant / refractory to prior intravenous or intraperitoneal platinum-based chemotherapy (up to three prior regimens)
- •- Taxane/platinum refractory/resistant patients must present with either measurable (by RECIST criteria) or non-measurable (based on both imaging and CA-125 evaluations) 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.
- •- Negative serum pregnancy test at screening (Not applicable to patients who are surgically sterilized or who are postmenopausal).
- •- Sexually active female patients must either be surgically sterilized, post-menopausal (no regular menstrual bleeding for at least 2 years) or practicing an acceptable form of birth control (i.e. double barrier method – intrauterine device plus condom, spermicidal gel plus condom)
- •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 epothilones, anthracyclines and/or pegylated liposomal doxorubicin
- •- Date of first study treatment would be more than 30 days past the screening CT scan (ScreeningCT scan must be performed within 6 months from last dose of platinum based chemotherapy confirming disease progression
- •- Any peripheral neuropathy > CTC grade 1
- •- Unresolved diarrhea of any grade within last 7 days prior to start of treatment.
- •- Presenting with symptomatic brain metastasis and/or 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 with the exception of low dose Coumadin® (1 mg or less daily) administered prophylactically for maintenance of in-dwelling lines or ports.(Wash-out period from therapeutic dose of Coumadin should be = 7 days)
- •- 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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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
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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. Favorable prognostic factors include young age, cell type other than clear cell or mucinous, lower stage, good performance status, small residual tumor volume after surgery, and absence of ascites. The prognosis of patients with resistant / refractory ovarian cancer is uniformly poor with median overall survival ranging from 35 – 41 weeks.EUCTR2004-005181-20-HUovartis Pharma Services AG810
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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
已完成
3 期
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