EUCTR2011-002172-16-ES进行中（未招募）不适用
A phase II Controlled Study of PM01183 in Platinum-Resistant / Refractory Advanced Ovarian Cancer Patients. - N.A.
Pharma Mar S.A. Sociedad Unipersonal0 个研究点目标入组 78 人开始时间: 2011年8月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
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
- •-Voluntary written informed consent (IC) before any study-specific procedure.
- •-Confirmed epithelial ovarian cancer.
- •-FIGO stages IIC and measurable disease.
- •-Platinum-resistant / refractory disease.
- •-Less than three prior lines of chemotherapy.
- •-Age> = 18 years.
- •-ECOG performance status (PS) <=2.
- •-Adequate hematological, renal, metabolic and hepatic function.
- •-No prior or concurrent invasive malignant disease with the last three years.
- •-At least three weeks since last prior chemotherapy.
- •-Negative serum pregnancy test in women of childbearing potential.
- •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 39
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •-Concomitant diseases / conditions.
- •-Platinum-sensitive disease.
- •-Prior treatment with Topotecan.
- •-Hipersensitivity to topotecan.
- •-Known or suspected brain metastases or leptomeningeal disease.
- •-Women who are pregnant or breast feeding.
- •-Prior pelvic irradiation with total doses >=45 Grays (Gy).
研究者
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