Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer
Phase II Study of Single Agent Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer With No Prior PARP Exposure or Prior PARP Inhibitor Exposure
研究概览
详细说明
Olaparib tablets will be taken twice daily, orally, in treatment cycles lasting 4 weeks.
On days 1, 8, 12 and 22 of the first 2 cycles and day 1 of all other cycles, subjects will have a physical exam, be asked questions about their general health, and specific questions about any problems they might be having and any medications they are taking.
Tumor will be assess by either CT or MRI scan every 2 cycles (every 2 months). Tumor biopsies will be optional in this study. Only participants that have received a PARP inhibitor in the past will be asked to have a biopsy of their tumor.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02215
- Dana-Farber Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically confirmed ovarian, peritoneal or fallopian tube cancer that has recurred following a platinum-based regimen used at initial diagnosis
- Measurable disease
- Estimated life expectancy greater than 16 weeks
- Normal organ and marrow function
- Evidence of non-childbearing status for women of childbearing potential
- Able to swallow oral medication
Exclusion Criteria:
- Pregnant or breastfeeding
- Prior PARP inhibitor use for another cancer such as breast cancer
- Receiving any other study agents or any other anti-cancer treatment
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- History of a different malignancy unless disease-free for at least 5 years
- Currently experiencing seizures or currently being treated with any anti-epileptic for seizures
- Human immunodeficiency virus (HIV) positive on combination antiretroviral therapy
- Presence of gastrointestinal disorders that, in the investigator's opinion, are likely to interfere with the absorption of olaparib, or with the patient's ability to take regular oral medication
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:PARP Inhibitor Naive
Patients with no prior PARP inhibitor treatment
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Tablet formulation will be used.
其他名称:
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有源比较器:Prior PARP Inhibitor
Patients previously treated with a PARP inhibitor other than olaparib
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Tablet formulation will be used.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Response Rates
大体时间:1 year
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To determine the RECIST 1.1.
response rates of the oral PARP inhibitor olaparib based on prior exposure of a PARP inhibitor; patients who have received and subsequently have had disease progression with a prior PARP inhibitor versus no prior exposure to a PARP inhibitor in patients with germline BRCA mutations who have recurrent ovarian, fallopian tube or peritoneal cancer who have measurable cancer.
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Toxicity
大体时间:1 year
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Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)
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1 year
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Progression free survival
大体时间:1 year
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Assess progression free survival (PFS) and 6 month PFS rate
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1 year
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Response Rate
大体时间:1 year
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Assess CA125 response rate
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1 year
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合作者和调查者
调查人员
- 首席研究员:Ursula A Matulonis, MD、Dana-Farber Cancer Institute
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Olaparib的临床试验
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