<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/NCT03026881</url>
  </required_header>
  <id_info>
    <org_study_id>FZPL-I-103-GC</org_study_id>
    <nct_id>NCT03026881</nct_id>
  </id_info>
  <brief_title>A Study of Fluzoparib Given in Combination With Apatinib and Paclitaxel in Gastric Cancer Patients</brief_title>
  <official_title>An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib and Paclitaxel in the 2nd Line Treatment of Patients With Recurrent or Metastatic Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Affiliated Hospital of the Chinese Academy of Military Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral&#xD;
      selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the&#xD;
      tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and&#xD;
      to see how well this three drugs work together in the treatment of patients with recurrent&#xD;
      and metastatic gastric cancer who progress following first-line therapy. The safety and&#xD;
      efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</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>DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>DLT and safety defined by CTC version 4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best of ORR</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DOR)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression (TTP)</measure>
    <time_frame>From date of enrollment until the date of first objective progression, assessed up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Up to 33 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal half life (t1/2)</measure>
    <time_frame>Up to 33 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC）</measure>
    <time_frame>Up to 33 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution (V/F)</measure>
    <time_frame>Up to 33 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Clearance (CL/F)</measure>
    <time_frame>Up to 33 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Recurrent and Metastatic Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Fluzoparib + Apatinib + Paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluzoparib</intervention_name>
    <description>Fluzoparib either at 20,30,40mg twice daily,capsule oral.</description>
    <arm_group_label>Fluzoparib + Apatinib + Paclitaxel</arm_group_label>
    <other_name>SHR3162</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Oral</description>
    <arm_group_label>Fluzoparib + Apatinib + Paclitaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Intravenous injection</description>
    <arm_group_label>Fluzoparib + Apatinib + Paclitaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ECOG performance status of 0 to 1.&#xD;
&#xD;
          -  Life expectancy of more than 12 weeks.&#xD;
&#xD;
          -  Histologically or cytologically confirmed gastric adenocarcinoma( adenocarcinoma of&#xD;
             the gastroesophageal junction included).&#xD;
&#xD;
          -  Recurrent or metastatic gastric cancer that has progressed following first&#xD;
             line-therapy.&#xD;
&#xD;
          -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed&#xD;
             by imaging (CT/MRI) at baseline&#xD;
&#xD;
          -  Subjects who have overall good overall general condition.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who received any previous treatment with any PARP inhibitors.&#xD;
&#xD;
          -  Subjects who received any previous treatment with any taxanes.&#xD;
&#xD;
          -  More than one prior chemotherapy regimen for the treatment of gastric cancer in the&#xD;
             metastatic or recurrent setting.&#xD;
&#xD;
          -  Less than 4 weeks from the last clinical trial.&#xD;
&#xD;
          -  Less than 2 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment&#xD;
             and target therapy.&#xD;
&#xD;
          -  Unstable hypertension.&#xD;
&#xD;
          -  Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.&#xD;
&#xD;
          -  Subjects with brain metastases.&#xD;
&#xD;
          -  Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.&#xD;
&#xD;
          -  Subjects with a known hypersensitivity to fluzoparib, apatinib, paclitaxel or any of&#xD;
             the excipients of the product.&#xD;
&#xD;
          -  Ongoing infection (determined by investigator).&#xD;
&#xD;
          -  History of immunodeficiency, including HIV-positive, suffering from other acquired,&#xD;
             congenital immunodeficiency disease, or history of organ transplantation.&#xD;
&#xD;
          -  Subjects who can not interrupt the using of the drugs that may cause QT prolongation&#xD;
             during study.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jianming Xu, MD</last_name>
    <email>jmxu2003@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Affiliated Hospital of Military Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianming Xu, MD</last_name>
      <email>jmxu2003@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>March 5, 2017</last_update_submitted>
  <last_update_submitted_qc>March 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PARP inhibitor</keyword>
  <keyword>VEGFR inhibitor</keyword>
  <keyword>Combination therapy</keyword>
  <keyword>Gastric cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Apatinib</mesh_term>
    <mesh_term>Fluzoparib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03026881
org study id: FZPL-I-103-GC
nct id: NCT03026881
lead sponsor: 
collaborator: 
has dmc: No
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral
      selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the
      tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and
      to see how well this three drugs work together in the treatment of patients with recurrent
      and metastatic gastric cancer who progress following first-line therapy. The safety and
      efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.
time frame: through study completion, an average of 6 months
description: DLT and safety defined by CTC version 4.0
measure: Best of ORR
time frame: through study completion, an average of 6 months
measure: Overall Response Rate (ORR)
time frame: through study completion, an average of 6 months
measure: Disease Control Rate (DOR)
time frame: through study completion, an average of 6 months
measure: Time to Progression (TTP)
time frame: From date of enrollment until the date of first objective progression, assessed up to 9 months
measure: Progression Free Survival (PFS)
time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months
measure: Maximum plasma concentration (Cmax)
time frame: Up to 33 days
measure: Terminal half life (t1/2)
time frame: Up to 33 days
measure: Area under the plasma concentration-time curve (AUC）
time frame: Up to 33 days
measure: Volume of distribution (V/F)
time frame: Up to 33 days
measure: Plasma Clearance (CL/F)
time frame: Up to 33 days
arm group label: Fluzoparib + Apatinib + Paclitaxel
arm group type: Experimental
intervention type: Drug
intervention name: Fluzoparib
description: Fluzoparib either at 20,30,40mg twice daily,capsule oral.
arm group label: Fluzoparib + Apatinib + Paclitaxel
other name: SHR3162
intervention type: Drug
intervention name: Apatinib
description: Oral
arm group label: Fluzoparib + Apatinib + Paclitaxel
intervention type: Drug
intervention name: Paclitaxel
description: Intravenous injection
arm group label: Fluzoparib + Apatinib + Paclitaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jianming Xu, MD
email: jmxu2003@yahoo.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Paclitaxel
mesh term: Apatinib
mesh term: Fluzoparib
sharing ipd: Undecided