<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04425876</url>
  </required_header>
  <id_info>
    <org_study_id>SHR3162-I-116</org_study_id>
    <nct_id>NCT04425876</nct_id>
  </id_info>
  <brief_title>A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is being conducted to: a) evaluate the tolerability and safety of the&#xD;
      co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer,&#xD;
      and establish a maximum tolerated dose and recommended phase II dose of the combination and&#xD;
      b) assess the efficacy of the co-administration of Fluzoparib and FOLFIRINOX in patients with&#xD;
      resectable pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 17, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with a dose limited toxicity</measure>
    <time_frame>28 Days (first and second cycle)</time_frame>
    <description>Number of participants with a dose limited toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum tolerated dose</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>Maximum tolerated dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RP2D</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>Recommended Phase 2 Dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>R0 resection rate</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AEs</measure>
    <time_frame>From the first drug administration to within 30 days for the last drug dose</time_frame>
    <description>Incidence of adverse events and associated dose of Fluzoparib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resection Rate</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MPR Rate</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Major pathological response rate based on central review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Objective response rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free-survival</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Disease-free-survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-Free-Survival</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Event-Free-Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall-Survival</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Overall-Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum concentration (Cmin)</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Minimum observed plasma concentration for Fluzoparib</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Fluzoparib+mFOLFIRINOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluzoparib</intervention_name>
    <description>Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy</description>
    <arm_group_label>Fluzoparib+mFOLFIRINOX</arm_group_label>
    <other_name>SHR3162</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-79 years.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1&#xD;
&#xD;
          -  Expected survival ≥ 6 months.&#xD;
&#xD;
          -  Histologically or cytologically confirmed pancreas adenocarcinoma.&#xD;
&#xD;
          -  Resectable or borderline resectable pancreatic cancer.&#xD;
&#xD;
          -  Adequate organ performance based on laboratory blood tests.&#xD;
&#xD;
          -  Presence of at least of one measurable lesion in agreement to RECIST criteria.&#xD;
&#xD;
          -  Ability to understand and the willingness to receive a needle biopsy.&#xD;
&#xD;
          -  Women of childbearing potential and men must agree to use adequate contraception prior&#xD;
             to study entry and for the duration of study participation.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had any chemotherapy or radiotherapy prior to entering the study.&#xD;
&#xD;
          -  Patients with metastasis disease.&#xD;
&#xD;
          -  Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to oxaliplatin, irinotecan, 5-Fluorouracil or other agents used in the&#xD;
             study.&#xD;
&#xD;
          -  Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks.&#xD;
&#xD;
          -  Significant cardiovascular disease such as New York Heart Associate Class III/IV,&#xD;
             cardiac failure, myocardial infarction, unstable arrhythmia, or evidence of ischemia&#xD;
             on ECG within 6 months prior to enrolment.&#xD;
&#xD;
          -  Patients unable to swallow orally administered medication and patients with&#xD;
             gastrointestinal disorders likely to interfere with absorption of the study&#xD;
             medication.&#xD;
&#xD;
          -  Patients with myelodysplastic syndrome/acute myeloid leukaemia.&#xD;
&#xD;
          -  Patients with second primary cancer except curatively treated in-situ cancer or slowly&#xD;
             progressing malignancy.&#xD;
&#xD;
          -  Known active hepatitis B or C infection.&#xD;
&#xD;
          -  History of immunodeficiency (including HIV infection) or organ transplantation.&#xD;
&#xD;
          -  Other serious accompanying illnesses, which, in the researcher's opinion, could&#xD;
             seriously adversely affect the safety of the treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boyong Shen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chunlei Jin, Ph.D</last_name>
    <phone>86-021-23511999</phone>
    <email>jinchunlei@hrglobe.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boyong Shen, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>December 30, 2020</last_update_submitted>
  <last_update_submitted_qc>December 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluzoparib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04425876
org study id: SHR3162-I-116
nct id: NCT04425876
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with a dose limited toxicity
time frame: 28 Days (first and second cycle)
description: Number of participants with a dose limited toxicity
measure: Maximum tolerated dose
time frame: Up to 8 months
description: Maximum tolerated dose
measure: RP2D
time frame: Up to 8 months
description: Recommended Phase 2 Dose
measure: R0 resection rate
time frame: Up to 2 years
description: R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
measure: AEs
time frame: From the first drug administration to within 30 days for the last drug dose
description: Incidence of adverse events and associated dose of Fluzoparib
measure: Resection Rate
time frame: Up to 2 years
description: Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
measure: MPR Rate
time frame: Up to 2 years
description: Major pathological response rate based on central review
measure: Objective response rate
time frame: Up to 2 years
description: Objective response rate
measure: Disease-free-survival
time frame: Up to 2 years
description: Disease-free-survival
measure: Event-Free-Survival
time frame: Up to 2 years
description: Event-Free-Survival
measure: Overall-Survival
time frame: Up to 2 years
description: Overall-Survival
measure: Minimum concentration (Cmin)
time frame: Up to 2 years
description: Minimum observed plasma concentration for Fluzoparib
arm group label: Fluzoparib+mFOLFIRINOX
arm group type: Experimental
description: Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy
intervention type: Drug
intervention name: Fluzoparib
description: Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy
arm group label: Fluzoparib+mFOLFIRINOX
other name: SHR3162
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Boyong Shen, M.D.
role: Principal Investigator
affiliation: Ruijin Hospital
last name: Chunlei Jin, Ph.D
phone: 86-021-23511999
email: jinchunlei@hrglobe.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Fluzoparib