Status:
UNKNOWN
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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 to...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04425876
Start Date
December 17 2020
End Date
September 1 2023
Last Update
December 31 2020
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China