Phase II Study of the PARP Inhibitor, Olaparib, in Adult Patients With Recurrent/Metastatic Ewing's Sarcoma Following Failure of Prior Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Objective Response Rate of Olaparib
研究概览
简要总结
This research study is a Phase II clinical trial to test the efficacy of Olaparib in adult participants with recurrent/metastatic Ewing's Sarcoma following failure of prior chemotherapy.
详细描述
Primary Objectives Evaluate the objective response rate of olaparib in adult patients with recurrent and/or metastatic Ewing's sarcoma following failure of conventional chemotherapy.
Secondary Objectives To evaluate the progression-free survival, overall survival, and safety of olaparib in this patient population (ie Number of Participants With Adverse Events). As an exploratory objective, the investigators will evaluate (in subjects who agree to an optional biopsy) differences in pre- and post-treatment tumor DNA alterations and differences in levels of protein and RNA expression related to PARP inhibition.
Study Design Potential subjects who discuss and sign the informed consent form will undergo screening studies. Eligible patients will administer olaparib and obtain restaging imaging studies after 6 and 12 weeks on study, and then every 8 weeks thereafter. Participants will remain on study drug until disease progression, onset of unacceptable toxicities, or subject withdraws consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed Ewing's sarcoma
- •Normal organ and bone marrow function
- •Life expectancy of at least 16 weeks
- •Not pregnant or breastfeeding
- •Willing and able to comply with the protocol for the duration of the study
- •Presence of measurable disease
排除标准
- •Involvement in the planning and/or conduct of ths study
- •Previous enrollment in the present study
- •Participation in another clinical study with an investigational product during the 21 days prior to first dose of study drug
- •Previous exposure to any PARP inhibitor
- •Receiving systemic chemotherapy or radiotherapy within 2 weeks of beginning study treatment
- •Receiving prohibited classes of inhibitors of CYP3A4
- •Persistent clinically significant toxicities caused by previous cancer therapy
- •Known myelodysplastic syndrome or acute myeloid leukemia
- •Symptomatic, uncontrolled brain metastases
- •Major surgery within 14 days of starting study treatment
- •Considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disorder or active, uncontrolled infection
- •Unable to swallow orally administered medication or with gastrointestinal disorders likely to interfere with absorption of the study medication
- •Known to be serologically positive for HIV and receiving antiretroviral therapy
- •Known active Hepatitis B or C
- •Known hypersensitivity to olaparib or any of the excipients of the product
- •Uncontrolled seizures
研究组 & 干预措施
Olaparib
400mg PO BID Continuous
干预措施: Olaparib (Drug)
结局指标
主要结局
Objective Response Rate of Olaparib
时间窗: 2 years
Number of participants with objective response rate as defined as PR+CR as determined by RECIST vs. 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Progression-Free Survival(Two years)
- Overall Survival(Two years)
- Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event(2 years)
研究者
Edwin Choy, MD
Principal Investigator
Massachusetts General Hospital