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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer, and establish the maximum tolerated dose and recommended phase II dose of the combination; and b) assess the efficacy of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• Aged ≥ 18 years.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1

• Expected survival ≥ 6 months.

• Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma.

• Documented mutation in germline BRCA1/2 or PALB2 that is predicted to be deleterious or suspected deleterious.

• Adequate organ performance based on laboratory blood tests.

• Presence of at least of one measurable lesion in agreement to RECIST criteria.

• 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 received any chemotherapy for the treatment of pancreatic cancer prior to entering the study.

• Previous treatment with any poly ADP-ribose polymerase (PARP) inhibitor.

• Patients who have had radiotherapy or participated in another clinical trial with any investigational agents within 28 days of enrolment (Day 1 visit).

• 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 of enrolment (Day 1 visit).

• Patients with known or suspected brain metastasis.

• 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.