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
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Response Rates
研究概览
简要总结
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.
详细描述
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PARP Inhibitor Naive
Patients with no prior PARP inhibitor treatment
干预措施: Olaparib (Drug)
Prior PARP Inhibitor
Patients previously treated with a PARP inhibitor other than olaparib
干预措施: Olaparib (Drug)
结局指标
主要结局
Response Rates
时间窗: 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.
次要结局
- Toxicity(1 year)
- Progression free survival(1 year)
- Response Rate(1 year)
研究者
Ursula A. Matulonis, MD
Principal Investigator
Dana-Farber Cancer Institute