EUCTR2009-015770-35-SK进行中（未招募）不适用
Phase II randomized trial of the Polo-like kinase 1 inhibitor BI 6727monotherapy versus investigator’s choice chemotherapy in ovariancancer patients resistant or refractory to platinum-based cytotoxictherapy - BI 6727 randomised phase II trial in ovarian cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •- Females, age = 18 years
- •- Confirmed epithelial ovarian cancer, peritoneal carcinoma or fallopian tube cancer
- •- Platinum-resistant disease (disease progression within a platinum-free interval of = 6 months after the final dose of primary or subsequent platinum-based therapy) or platinum-refractory disease (disease progression during primary or subsequent platinum-based therapy. Stable disease as best response to primary or subsequent Platinum-based therapy )
- •- The patient has completed at least two and up to three chemotherapy regimens for the management of this condition, one of which may have been treatment for platinum resistant or refractory disease. Treatment may have included intraperitoneal therapy, consolidation or extended therapy after surgical or non surgical assessment.
- •- ECOG performance status = 2
- •- Life expectancy = 3 months
- •- At least, one measurable or non-measurable lesion according to RECIST 1.1
- •- Adequate hepatic, renal and bone marrow functions
- •- Signed and dated written informed consent prior to admission to the study
- •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
- •- Contre-indications for cytotoxic treatment according to the SPC (Arm B)
- •- Clinical evidence of active brain metastasis or leptomeningeal involvement
- •- Other malignancy currently requiring active therapy
- •- QTcF prolongation deemed clinically relevant by the investigator (e.g., congenital long QT syndrome, QTcF > 470ms etc.)
- •- Hypersensitivity to one of the trial drugs or the excipients
- •- Serious illness or concomitant non-oncological disease
- •- Systemic anticancer therapy within 4 weeks before the start of the study.
研究者
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