A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    74
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 27 January 2021

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.

Details
Condition Pancreatic Cancer, Pancreatic Cancer, Islet Ce417ll Cancer, Pancreatic disorder, Pancreatic Disorders, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Pancreatic Disorders, Islet Ce417ll Cancer, Digestive System Neoplasms, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment Fluzoparib
Clinical Study IdentifierNCT04425876
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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