Pancreatic Cancer
Conditions
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.
Interventions
DRUGFluzoparib
Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a dose limited toxicity | 28 Days (first and second cycle) | Number of participants with a dose limited toxicity |
| Maximum tolerated dose | Up to 8 months | Maximum tolerated dose |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AEs | From the first drug administration to within 30 days for the last drug dose | Incidence of adverse events and associated dose of Fluzoparib |
| Resection Rate | Up to 2 years | Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer |
| MPR Rate | Up to 2 years | Major pathological response rate based on central review |
| Objective response rate | Up to 2 years | Objective response rate |
| Disease-free-survival | Up to 2 years | Disease-free-survival |
| Event-Free-Survival | Up to 2 years | Event-Free-Survival |
| Overall-Survival | Up to 2 years | Overall-Survival |
| Minimum concentration (Cmin) | Up to 2 years | Minimum observed plasma concentration for Fluzoparib |
Countries
China
Contacts
Primary ContactChunlei Jin, Ph.D
Outcome results
None listed