EUCTR2005-005024-14-IT进行中（未招募）不适用
multicenter, randomized, double-blind, parallel-arm, two-stage study of the efficacy and safety of AVE0005 VEGF Trap administered intravenously every 2 weeks in patients with platinum-resistant and topotecan- and/or liposomal doxorubicin-resistant advanced ovarian cancer - ND
Sanofi-Synthelabo Recherche, a subsidiary of sanofi-aventis group0 个研究点目标入组 200 人开始时间: 2006年8月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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 ovarian epithelial including fallopian tube and primary peritoneal adenocarcinoma. Prior treatment with at least 2 treatment regimens in the advanced disease treatment setting. Platinum-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance. Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance. Evidence of at least one unidimensionally measurable tumor lesion by CT or MRI scan according to Response Evaluation Criteria in Solid Tumors RECIST that has not been treated with surgery or radiation therapy
- •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
- •Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri. Prior treatment with a VEGF or VEGF receptor inhibitor More than 3 chemotherapy regimens in the advanced disease treatment setting Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks 6 weeks for nitrosoureas, mitomycin C, immunotherapy, or cytokine therapy of study enrollment. Uncontrolled hypertension, defined as blood pressure 150/100 mm Hg NCI CTCAE v.3.0 grade 8805;2 , or systolic blood pressure 180 mm Hg if diastolic blood pressure 90 mm Hg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment
研究者
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