NCT00753545已完成2 期
Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
研究概览
简要总结
The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
- •Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the penultimate chemo regimen.
- •For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
- •Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.
排除标准
- •Previous treatment with PARP inhibitors including AZD2281
- •Patients with low grade ovarian carcinoma.
- •Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
- •Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).
研究组 & 干预措施
1
Experimental
AZD2281
干预措施: AZD2281 (Drug)
2
Placebo Comparator
matching placebo
干预措施: matching placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST])
时间窗: Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.
PFS was defined as the time from randomisation to the earlier date of radiological progression (per RECIST criteria) or death by any cause in the absence of objective progression. \[Full analysis set (FAS)\]
次要结局
- Objective Response Rate (ORR) (According to RECIST)(Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
- Disease Control Rate(Assessed at 24 weeks. Radiologic scans performed at baseline, week 12 (+/- 1 week) and week 24 (+/- 1 week).)
- Duration of Response(Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
- FACT-O Symptom Index (FOSI) Time to Worsening(Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.)
- Trial Outcome Index(TOI)Time to Worsening(Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.)
- Percentage Change From Baseline in Tumour Size at Week 24(Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
- Best Percentage Change in Cancer Antigen 125 (CA-125) Levels(CA-125 was measured at baseline then every 28 days on treatment, assessed maximum up to 14 months.)
- Overall Survival (OS)(Follow up every 12 weeks post progression, assessed maximum up to 90 months.)
- Best Objective Response(Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter, assessed maximum up to 14 months.)
- Improvement Rate for Trial Outcome Index (TOI)(Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.)
- RECIST and CA-125 Response Separately and Combined(Radiologic scans performed at baseline then every 12 weeks (+/- 1week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.)
- Improvement Rate for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)(Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.)
- Time to Earlier of CA-125 or RECIST Progression(Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/- 1 week) thereafter and monthly for CA-125 measurements, assessed maximum up to 14 months.)
- Improvement Rate for FACT-O Symptom Index (FOSI)(Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.)
- Functional Analysis of Cancer Therapy - Ovarian (FACT-O) Time to Worsening(Patient reported outcome questionnaire completed at baseline then every 28 days up to disease progression, assessed maximum up to 14 months.)
研究者
研究点 (1)
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