<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/NCT03020979</url>
  </required_header>
  <id_info>
    <org_study_id>BYEC20161201</org_study_id>
    <nct_id>NCT03020979</nct_id>
  </id_info>
  <brief_title>A Clinical Trial With Apatinib for Subjects With Refractory Malignant Ascites</brief_title>
  <official_title>A Phase II, Single-Arm, Open-Label, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Apatinib in Patients With Refractory Malignant Ascites</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Bengbu Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Bengbu Medical College</source>
  <brief_summary>
    <textblock>
      Malignant ascites is a severe complication of many types of human cancer. Animal and clinical&#xD;
      analyses have shown that angiogenesis plays a critical role in the formation of malignant&#xD;
      ascites. Therefore, drugs such as apatinib that target angiogenesis may control the&#xD;
      development of malignant ascites. The study is to evaluate the efficacy and safety of&#xD;
      apatinib in patients with refractory malignant ascites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is to investigate the efficacy and safety of apatinib in patients with refractory&#xD;
      malignant ascites. A total of 120 patients with performance status 0-2 were enrolled in this&#xD;
      study and 500mg apatinib tablets were administered orally, once daily until disease&#xD;
      progression or intolerable toxicity or patients withdrawal of consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2</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>The repeat paracentesis response rate (proportion of subjects who have a doubling of baseline time to repeat paracentesis)</measure>
    <time_frame>12 weeks after initiation of study treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The time to the need for the first repeat abdominal paracentesis after the start of apatinib therapy as compared with historical control data.</measure>
    <time_frame>12 weeks after initiation of study treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean number of paracentesis procedures required in each patient over the course of three months.</measure>
    <time_frame>12 weeks after the initiation of study treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of apatinib therapy on quality of life in patients with malignant ascites by using EORTC QLQ-C30 V3.0.</measure>
    <time_frame>12 weeks after the initiation of study treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Malignant Ascites</condition>
  <condition>Apatinib</condition>
  <arm_group>
    <arm_group_label>500mg apatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 500mg of apatinib tablet orally, once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apatinib</intervention_name>
    <description>Patients will take 500mg apatinib daily orally.</description>
    <arm_group_label>500mg apatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persistent or symptomatic ascites with positive cytology secondary to any&#xD;
             histologically confirmed tumor type not amenable to cytoreductive surgery or&#xD;
             additional chemotherapy&#xD;
&#xD;
          -  Patients may enroll in this study irrespective of previous therapy including&#xD;
             diuretics, surgery, chemotherapy, immunotherapy and radiation therapy&#xD;
&#xD;
          -  Must have received a minimum of two paracentesis procedures and a trial of diuretic&#xD;
             therapy within 60 days of study entry&#xD;
&#xD;
          -  Age Restrictions: 18-75 years&#xD;
&#xD;
          -  Life Expectancy: 12 weeks or more&#xD;
&#xD;
          -  ECOG Performance Status: 0-2&#xD;
&#xD;
          -  Able and willing to provide informed consent and comply with study and/or follow-up&#xD;
             procedures&#xD;
&#xD;
          -  Normal organ and marrow function as defined by: Leukocytes &gt;/= 3,000/mcL; Absolute&#xD;
             neutrophil count &gt;/= 1,500/mcL; Platelets &gt;/= 100,000/mcL; Total bilirubin within&#xD;
             normal institutional limits; AST (SGOT)/ALT(SGPT) &lt;/= 2.5 X institutional upper limit&#xD;
             of normal (ULN); Creatinine within normal institutional limits OR Creatinine clearance&#xD;
             &gt;/+ 60 mL/min for patients with creatinine levels above the institutional normal;&#xD;
             Serum Potassium within normal institutional limits; Serum Sodium within normal&#xD;
             institutional limits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having received anti-angiogenic agents as part of the treatment of their&#xD;
             malignancy within 60 days prior to study entry&#xD;
&#xD;
          -  Current, recent (within 30 days of the first infusion of this study) or planned&#xD;
             administration of chemotherapy (including all routes of administration),&#xD;
             immunotherapy, biologic therapy, radiation therapy or any other anti-angiogenic&#xD;
             therapy (e.g., bevacizumab, other tyrosine kinase inhibitors)&#xD;
&#xD;
          -  Current, recent (within 30 days of the first infusion of this study), or planned&#xD;
             participation in any other experimental drug study&#xD;
&#xD;
          -  Pregnant women; A serum pregnancy test will be given to females of childbearing&#xD;
             potential prior to study enrollment and the participant must agree to use adequate&#xD;
             contraception (barrier or hormonal methods) prior to study entry and for the duration&#xD;
             of study participation.&#xD;
&#xD;
          -  Un-controlled hypertension (defined as systolic blood pressure &gt; 140 mmHg and/or&#xD;
             diastolic blood pressure &gt; 90 mmHg&#xD;
&#xD;
          -  History of hypertensive crisis or hypertensive encephalopathy&#xD;
&#xD;
          -  New York Heart Association (NYHA) Grade III or greater congestive heart failure&#xD;
&#xD;
          -  History of myocardial infarction, unstable angina, stroke or transient ischemic attack&#xD;
             within 6 months prior to study entry&#xD;
&#xD;
          -  Known CNS disease, except for treated brain metastasis.&#xD;
&#xD;
          -  Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or&#xD;
             recent peripheral arterial thrombosis) within 6 months prior to study entry&#xD;
&#xD;
          -  History of gastrointestinal hemorrhage within 6 month prior to study entry&#xD;
&#xD;
          -  Evidence of bleeding diathesis or significant coagulopathy (in the absence of&#xD;
             therapeutic anticoagulation)&#xD;
&#xD;
          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days&#xD;
             prior to study entry or anticipation of need for major surgical procedure during the&#xD;
             course of the study&#xD;
&#xD;
          -  Core biopsy or other minor surgical procedure, excluding placement of a vascular&#xD;
             access device or paracentesis/thoracentesis, within 7 days prior to study entry&#xD;
&#xD;
          -  History of abdominal fistula or gastrointestinal perforation within 6 months prior to&#xD;
             study entry&#xD;
&#xD;
          -  Any bowel obstruction that has not fully recovered despite medical or surgical&#xD;
             intervention prior to study entry&#xD;
&#xD;
          -  Evidence of bowel wall thickening outside the site of the known primary malignancy on&#xD;
             baseline radiographs&#xD;
&#xD;
          -  Serious, non-healing wound, active ulcer, or untreated bone fracture&#xD;
&#xD;
          -  Proteinuria as demonstrated by a Urine Protein/Creatinine ration &gt;/= 1.0 at screening&#xD;
&#xD;
          -  Known hypersensitivity to any component of apatinib.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Qiong Wu, M.D. Ph.D.</last_name>
    <phone>+86-552-3074480</phone>
    <email>byzlnk@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Qiong Wu</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rui Wang, MD</last_name>
      <phone>+86-0552-3074480</phone>
      <email>byzlnk@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>May 30, 2017</last_update_submitted>
  <last_update_submitted_qc>May 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital Bengbu Medical College</investigator_affiliation>
    <investigator_full_name>Qiong Wu</investigator_full_name>
    <investigator_title>M.D. Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascites</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</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/NCT03020979
org study id: BYEC20161201
nct id: NCT03020979
lead sponsor: 
Malignant ascites is a severe complication of many types of human cancer. Animal and clinical
      analyses have shown that angiogenesis plays a critical role in the formation of malignant
      ascites. Therefore, drugs such as apatinib that target angiogenesis may control the
      development of malignant ascites. The study is to evaluate the efficacy and safety of
      apatinib in patients with refractory malignant ascites.
The study is to investigate the efficacy and safety of apatinib in patients with refractory
      malignant ascites. A total of 120 patients with performance status 0-2 were enrolled in this
      study and 500mg apatinib tablets were administered orally, once daily until disease
      progression or intolerable toxicity or patients withdrawal of consent.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The repeat paracentesis response rate (proportion of subjects who have a doubling of baseline time to repeat paracentesis)
time frame: 12 weeks after initiation of study treatment
measure: The time to the need for the first repeat abdominal paracentesis after the start of apatinib therapy as compared with historical control data.
time frame: 12 weeks after initiation of study treatment
measure: The mean number of paracentesis procedures required in each patient over the course of three months.
time frame: 12 weeks after the initiation of study treatment
measure: The effect of apatinib therapy on quality of life in patients with malignant ascites by using EORTC QLQ-C30 V3.0.
time frame: 12 weeks after the initiation of study treatment
arm group label: 500mg apatinib
arm group type: Experimental
description: Patients will receive 500mg of apatinib tablet orally, once daily.
intervention type: Drug
intervention name: Apatinib
description: Patients will take 500mg apatinib daily orally.
arm group label: 500mg apatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Qiong Wu, M.D. Ph.D.
phone: +86-552-3074480
email: byzlnk@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital Bengbu Medical College
investigator full name: Qiong Wu
investigator title: M.D. Ph.D.
mesh term: Ascites
mesh term: Apatinib