Clinical trial NCT04425876: A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with a dose limited toxicity
timeFrame: 28 Days (first and second cycle)
measure: Maximum tolerated dose
timeFrame: Up to 8 months
measure: RP2D
timeFrame: Up to 8 months
measure: R0 resection rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: AEs
timeFrame: From the first drug administration to within 30 days for the last drug dose
measure: Resection Rate
timeFrame: Up to 2 years
measure: MPR Rate
timeFrame: Up to 2 years
measure: Objective response rate
timeFrame: Up to 2 years
measure: Disease-free-survival
timeFrame: Up to 2 years
measure: Event-Free-Survival
timeFrame: Up to 2 years
measure: Overall-Survival
timeFrame: Up to 2 years
measure: Minimum concentration (Cmin)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Boyong Shen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: