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Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer

2012年8月18日 更新者:Ursula A. Matulonis, MD、Dana-Farber Cancer Institute

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

This research study is a way of gaining new knowledge about a drug called olaparib in women who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1) or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from repairing their DNA. In this research study, we are looking to see how well the drug olaparib works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well as those who have received a prior PARP inhibitor and whose cancer has re-grown after receiving that PARP inhibitor.

研究概览

地位

撤销

干预/治疗

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

介入性

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Dana-Farber Cancer Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
有源比较器:PARP Inhibitor Naive
Patients with no prior PARP inhibitor treatment
Tablet formulation will be used.
其他名称:
  • AZD2281
有源比较器:Prior PARP Inhibitor
Patients previously treated with a PARP inhibitor other than olaparib
Tablet formulation will be used.
其他名称:
  • AZD2281

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
Response Rates
大体时间:1 year
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.
1 year

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
Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)
1 year
Progression free survival
大体时间:1 year
Assess progression free survival (PFS) and 6 month PFS rate
1 year
Response Rate
大体时间:1 year
Assess CA125 response rate
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ursula A Matulonis, MD、Dana-Farber Cancer Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年8月1日

初级完成 (实际的)

2012年8月1日

研究完成 (实际的)

2012年8月1日

研究注册日期

首次提交

2011年10月24日

首先提交符合 QC 标准的

2012年8月7日

首次发布 (估计)

2012年8月10日

研究记录更新

最后更新发布 (估计)

2012年8月21日

上次提交的符合 QC 标准的更新

2012年8月18日

最后验证

2012年8月1日

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

3
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