NCT04300114终止3 期
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Fluzoparib Monotherapy in Patients With gBRCA/PALB2 Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 23
- 主要终点
- PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1
研究概览
简要总结
The study is being conducted to evaluate the tolerability, safety and efficacy of maintenance Fluzoparib monotherapy in patients with gBRCA/PALB2 mutated metastatic pancreatic cancer whose disease has not progressed on first line platinum based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Aged ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- •Expected survival ≥ 3 months.
- •Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
- •Patients who have received a minimum of 16 weeks of continuous platinum treatment for metastatic disease and have no evidence of progression based on investigator's opinion.
- •Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT or MRI.
- •Documented mutation in germline BRCA1/2 or PALB2 that is predicted to be deleterious or suspected deleterious.
- •Adequate organ performance based on laboratory blood tests.
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
- •Patients who have had radiotherapy within 2 weeks or participated in another clinical trial with any investigational agents within 2 weeks prior to study screening.
- •Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks.
- •Significant cardiovascular disease such as New York Heart Associate Class III/IV, cardiac failure, myocardial infarction, unstable arrhythmia, or evidence of ischemia on ECG within 6 months prior to enrolment.
- •Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •Patients with myelodysplastic syndrome/acute myeloid leukaemia.
- •Known active hepatitis B or C infection.
- •History of immunodeficiency (including HIV infection) or organ transplantation.
- •Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
研究组 & 干预措施
Maintenance Fluzoparib monotherapy
Experimental
干预措施: Fluzoparib (Drug)
Maintenance placebo monotherapy
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1
时间窗: up to 3 years
Progression-Free-Survival
次要结局
- DCR by BICR Using RECIST v1.1(up to 3 years)
- ORR by BICR Using RECIST v1.1(up to 3 years)
- OS(up to 3 years)
- DoR by BICR Using RECIST v1.1(up to 3 years)
- PFS by Investigators Using RECIST v1.1(up to 3 years)
- ORR by Investigators Using RECIST v1.1(up to 3 years)
- DCR by Investigators Using RECIST v1.1(up to 3 years)
- DoR by Investigators Using RECIST v1.1(up to 3 years)
- Number of participants with treatment-emergent adverse events(From the first drug administration to within 30 days for the last drug dose)
研究者
研究点 (23)
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