A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Progressive or recurrent disease after platinum-based chemotherapy
- •Measurable disease by RECIST
排除标准
- •Previous anthracycline treatment
- •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
3
AZD2281 Oral 400 mg BID
干预措施: AZD2281 (Drug)
1
AZD2281 Oral 200 mg BID
干预措施: AZD2281 (Drug)
2
Liposomal Doxorubicin
干预措施: Liposomal Doxorubicin (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)
PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)
次要结局
- Objective Response Rate (ORR)(At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009))
- Confirmed RECIST Response and/or CA-125 Response(At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009))
- Overall Survival (OS)(At the time of the cut-off for the final analysis of overall survival (30 April 2010))
- Overall Duration of Response(At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009))
- Disease Control Rate(At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009))
- Best Percentage Change in Tumour Size(At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009))
- Best Percentage Change From Baseline in CA-125 Levels(At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009))
- Best Quality of Life (QoL) Response for Trial Outcome Index (TOI)(At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009))
- Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)(At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009))
- Best QoL Response for FACT-O Symptom Index (FOSI)(At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009))