NCT03509636已完成1 期
An Open-Label Study to Assess the Efficacy And Safety of Poly(ADP-ribose) Polymerase Inhibitor Fluzoparib（SHR3162）in Patients With Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer and BRCA1/2 Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- ORR by RECIST v1.1
研究概览
简要总结
This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer.
详细描述
Fluzoparib (SHR-3162) is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) 1/2 being developed for treatment of BRCA1/2-mutant solid tumor. The tolerability, safety and PK of fluzoparib has been evaluated in Phase 1 study. An oral formulation is the focus of current development efforts.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of high grade serous or Grade 2/3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer；
- •Confirmed documented BRCA1/2 mutation;
- •Received 2~4 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen；
- •Relapsed/progressive disease as confirmed by radiologic assessment；
- •Have measurable disease as defined by RECIST v1.1.
排除标准
- •Any previous treatment with a PARP inhibitor;
- •Patient with any other malignancy which has been active or treated within the previous 5 years;
- •Patients with symptomatic uncontrolled brain metastases;
- •Patients unable to swallow orally administered medication.
研究组 & 干预措施
Treatment
Experimental
Fluzoparib capsule
干预措施: Fluzoparib (Drug)
结局指标
主要结局
ORR by RECIST v1.1
时间窗: every 8 weeks (±7 days) of treatment
Objective response rate
次要结局
- Response rate by GCIG CA-125(every 8 weeks (±7 days) of treatment expected to last for ~2 years)
- Incidence of adverse events, clinical laboratory abnormalities, and dose modifications(Every day starting with signing of consent until 30 days after discontinuation of treatment)
- DoR(study data collection expected to last for ~2 years)
- PFS(expected to last for ~2 years)
- OS(study data collection expected to last for ~2 years)
- Trough (Cmin) level of fluzoparib concentrations(Cycle 1 to cycle 4(each cycle is 28 days))
研究者
研究点 (1)
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