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

Overview

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.

Full Title of Study: “A Phase Ib/II Study to Assess the Tolerability, Safety and Efficacy of Fluzoparib in Combination With mFOLFIRINOX Followed by Fluzoparib Maintenance Monotherapy in Patients With Advanced Pancreatic Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 1, 2022

Interventions

  • Drug: Fluzoparib
    • PARP
  • Drug: Fluzoparib placebo
    • Placebo
  • Drug: mFOLFIRINOX
    • mFOLFIRINOX

Arms, Groups and Cohorts

  • Experimental: Fluzoparib+mFOLFIRINOX
    • Fluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy
  • Placebo Comparator: Placebo+mFOLFIRINOX
    • Placebo+mFOLFIRINOX followed by placebo maintenance monotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With a Dose Limited Toxicity
    • Time Frame: Within 28 Days after The First Dose
  • Maximum Tolerated Dose
    • Time Frame: Time Frame: Up to 8 months
  • Objective Response Rate
    • Time Frame: From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)

Secondary Measures

  • Adverse events evaluated by NCI CTCAE v5.0
    • Time Frame: From the first drug administration to within 30 days for the last drug dose
    • Incidence of adverse events and associated dose of Fluzoparib
  • Disease Control Rate
    • Time Frame: From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)
  • Duration of Response
    • Time Frame: Up to 2 years
  • Progression-Free-Survival
    • Time Frame: Up to 2 years
  • Overall-Survival
    • Time Frame: Up to 2 years
  • Area under the curve (AUC)
    • Time Frame: 1 year
    • Area under the plasma concentration time curve from 0 to 24 hours for Fluroparib
  • Maximum concentration (Cmax)
    • Time Frame: 1 year
    • Maximum observed plasma concentration for Fluzoparib
  • Time to maximum concentration (Tmax)
    • Time Frame: 1 year
    • Time to maximum plasma concentration for Fluzoparib

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangsu HengRui Medicine Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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