A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer
- Registration Number
- NCT04425876
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 74
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fluzoparib+mFOLFIRINOX Fluzoparib Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy
- Primary Outcome Measures
Name Time Method Number of participants with a dose limited toxicity 28 Days (first and second cycle) Number of participants with a dose limited toxicity
RP2D Up to 8 months Recommended Phase 2 Dose
R0 resection rate 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 Up to 8 months Maximum tolerated dose
- Secondary Outcome Measures
Name Time Method Event-Free-Survival Up to 2 years Event-Free-Survival
Overall-Survival Up to 2 years Overall-Survival
Resection Rate Up to 2 years Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
Objective response rate Up to 2 years Objective response rate
Disease-free-survival Up to 2 years Disease-free-survival
AEs From the first drug administration to within 30 days for the last drug dose Incidence of adverse events and associated dose of Fluzoparib
MPR Rate Up to 2 years Major pathological response rate based on central review
Minimum concentration (Cmin) Up to 2 years Minimum observed plasma concentration for Fluzoparib
Trial Locations
- Locations (1)
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China