NCT04425876Unknown1 期
A Phase I Study to Assess the Tolerability, Safety and Efficacy of Fluzoparib in Combination With mFOLFIRINOX as Neoadjuvant and Adjuvant Therapy in Patients With Resectable Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Number of participants with a dose limited toxicity
研究概览
简要总结
The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer, and establish a maximum tolerated dose and recommended phase II dose of the combination and b) assess the efficacy of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-79 years.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- •Expected survival ≥ 6 months.
- •Histologically or cytologically confirmed pancreas adenocarcinoma.
- •Resectable or borderline resectable pancreatic cancer.
- •Adequate organ performance based on laboratory blood tests.
- •Presence of at least of one measurable lesion in agreement to RECIST criteria.
- •Ability to understand and the willingness to receive a needle biopsy.
- •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
- •Patients who have had any chemotherapy or radiotherapy prior to entering the study.
- •Patients with metastasis disease.
- •Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan, 5-Fluorouracil or other agents used in the study.
- •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.
- •Patients with second primary cancer except curatively treated in-situ cancer or slowly progressing malignancy.
- •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
Fluzoparib+mFOLFIRINOX
Experimental
Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy
干预措施: Fluzoparib (Drug)
结局指标
主要结局
Number of participants with a dose limited toxicity
时间窗: 28 Days (first and second cycle)
Number of participants with a dose limited toxicity
RP2D
时间窗: Up to 8 months
Recommended Phase 2 Dose
R0 resection rate
时间窗: Up to 2 years
R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
Maximum tolerated dose
时间窗: Up to 8 months
Maximum tolerated dose
次要结局
- Event-Free-Survival(Up to 2 years)
- Overall-Survival(Up to 2 years)
- Resection Rate(Up to 2 years)
- Objective response rate(Up to 2 years)
- Disease-free-survival(Up to 2 years)
- AEs(From the first drug administration to within 30 days for the last drug dose)
- MPR Rate(Up to 2 years)
- Minimum concentration (Cmin)(Up to 2 years)
研究者
研究点 (1)
Loading locations...
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