A Phase II Open-label, Non-comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Ovarian Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)
研究概览
简要总结
The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Advanced ovarian cancer with positive BRCA1 or BRCA2 status
- •Failed at least one prior chemotherapy
- •In investigators opinion, no curative standard therapy exists
- •Measurable disease
排除标准
- •Brain metastases
- •Less than 28 days since last treatment used to treat the disease
- •Considered a poor medical risk due to a serious uncontrolled disorder
研究组 & 干预措施
KU-0059436 (AZD2281) 100 mg BID
干预措施: KU-0059436 (AZD2281)(PARP inhibitor) (Drug)
KU-0059436 (AZD2281) 400 mg BID
干预措施: KU-0059436 (AZD2281)(PARP inhibitor) (Drug)
结局指标
主要结局
Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)
时间窗: Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Duration of Response(End of study)
- Best Percentage Change in Tumour Size(End of study)
- Clinical Benefit (CB)(End of study)
- Progression-Free Survival (PFS)(End of study)