<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/NCT03262545</url>
  </required_header>
  <id_info>
    <org_study_id>Ahead-OV-201704</org_study_id>
    <nct_id>NCT03262545</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer</brief_title>
  <official_title>Efficacy and Safety of Apatinib As Third Line Therapy in Patients With Advanced Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sichuan Cancer Hospital and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sichuan Cancer Hospital and Research Institute</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 to investigate the efficacy and safety of apatinib in patients with advanced&#xD;
      ovarian cancer,who has received second-line chemotherapy and failed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian cancer is the third most common gynecological malignancy，just less than endometrial&#xD;
      cancer and cervical cancer. Because most patients with advanced ovarian cancer can not get&#xD;
      the ideal tumor cell reduction surgery, and multi-drug resistance often emerges after&#xD;
      repeated chemotherapy，recurrent and metastatic ovarian cancer has become one of the major&#xD;
      diseases that threaten women's health. There is strongly necessary to explore effective&#xD;
      therapeutic drugs and means to improve prognosis of these patients and improve the quality of&#xD;
      life. The study，as a double blind clinical trial ,is to investigate the efficacy and safety&#xD;
      of apatinib in patients with advanced ovarian cancer,who has received second-line&#xD;
      chemotherapy regimens and failed. A total of 60 patients with performance status 0-2 were&#xD;
      enrolled in this study, and were randomly divided into two groups--one group of 40 patients&#xD;
      receiving apatinib，and another of 20 patients receiving placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 27, 2017</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>approximately 2 years</time_frame>
    <description>Time from randomization until disease progression or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>approximately 2 years</time_frame>
    <description>Time from randomization until death from any cause of death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>approximately 2 years</time_frame>
    <description>Proportion of patients with reduction in tumor burden of a predefined amount</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease control rate (DCR)</measure>
    <time_frame>approximately 2 years</time_frame>
    <description>the total proportion of patients who demonstrate a response to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL)</measure>
    <time_frame>approximately 2 years</time_frame>
    <description>As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Angiogenesis Inhibitors，Ovarian Neoplasms</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>apatinib 500 mg p.o. once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo p.o. once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>apatinib</intervention_name>
    <description>Patients in experimental group will take 500mg apatinib daily orally，and patients in control group will take placebo</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Physical properties of placebos are consistent with apatinib</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years to 70 years;&#xD;
&#xD;
          2. Had a histologically or cytologically confirmed diagnosis of epithelial ovarian&#xD;
             cancer；&#xD;
&#xD;
          3. unfit for radical surgery and had received second-line chemotherapy，the disease still&#xD;
             progressed or can not tolerate the chemotherapy;&#xD;
&#xD;
          4. Had a disease status that was measurable or evaluable as defined by Response&#xD;
             Evaluation Criteria in Solid Tumors (RECIST, version1.1);&#xD;
&#xD;
          5. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or&#xD;
             2;&#xD;
&#xD;
          6. Had a life expectancy of at least 12 weeks;&#xD;
&#xD;
          7. Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥90g/L,&#xD;
             platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper&#xD;
             limit of normal (ULN), and b) ALT and AST≤2.5×the ULN (If liver metastases, serum&#xD;
             creatine ≤ 1.5 x ULN);&#xD;
&#xD;
          8. Had not gastrointestinal diseases that lead to malabsorption or impact Drug&#xD;
             absorption;&#xD;
&#xD;
          9. had good compliance;&#xD;
&#xD;
         10. Signed and dated informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients who had received anti-vascular therapy;&#xD;
&#xD;
          2. Allergic to any ingredients of Apatinib;&#xD;
&#xD;
          3. Participated in other drug clinical researchers within four weeks;&#xD;
&#xD;
          4. Have a variety of factors that affect oral medication (such as can not swallow,&#xD;
             gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.)&#xD;
&#xD;
          5. Severe infection;&#xD;
&#xD;
          6. Patients with serious cardiovascular diseases,such as unstable angina, grade 3-4 heart&#xD;
             dysfunction (NYHA Standard), congestive heart failure, poor-controlled arterial&#xD;
             hypertension despite standard medical management;&#xD;
&#xD;
          7. Patients who received major surgical operations within 4 weeks before screening;&#xD;
&#xD;
          8. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident&#xD;
             (including transient ischemic attack), deep venous thrombosis and pulmonary embolism,&#xD;
             etc., within 12 months before screening;&#xD;
&#xD;
          9. Past or concurrent with other malignancies, except for cured skin basal cell carcinoma&#xD;
             and cervical in situ cancer;&#xD;
&#xD;
         10. Have a history of psychiatric abuse and can not quit or have mental disorders.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mei Kai, Ph.D</last_name>
    <phone>18111277629</phone>
    <email>250450418@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sichuan Cancer Hospital</name>
      <address>
        <city>Chendu</city>
        <state>Sichuan</state>
        <zip>600000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kai Mei, Phd</last_name>
      <phone>13011827280</phone>
      <email>250450418@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sichuan Cancer Hospital and Research Institute</investigator_affiliation>
    <investigator_full_name>Mei Kai</investigator_full_name>
    <investigator_title>associate senior doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apatinib</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/NCT03262545
org study id: Ahead-OV-201704
nct id: NCT03262545
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is to investigate the efficacy and safety of apatinib in patients with advanced
      ovarian cancer,who has received second-line chemotherapy and failed.
Ovarian cancer is the third most common gynecological malignancy，just less than endometrial
      cancer and cervical cancer. Because most patients with advanced ovarian cancer can not get
      the ideal tumor cell reduction surgery, and multi-drug resistance often emerges after
      repeated chemotherapy，recurrent and metastatic ovarian cancer has become one of the major
      diseases that threaten women's health. There is strongly necessary to explore effective
      therapeutic drugs and means to improve prognosis of these patients and improve the quality of
      life. The study，as a double blind clinical trial ,is to investigate the efficacy and safety
      of apatinib in patients with advanced ovarian cancer,who has received second-line
      chemotherapy regimens and failed. A total of 60 patients with performance status 0-2 were
      enrolled in this study, and were randomly divided into two groups--one group of 40 patients
      receiving apatinib，and another of 20 patients receiving placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Progression-free survival (PFS)
time frame: approximately 2 years
description: Time from randomization until disease progression or death
measure: Overall survival (OS)
time frame: approximately 2 years
description: Time from randomization until death from any cause of death
measure: Objective response rate (ORR)
time frame: approximately 2 years
description: Proportion of patients with reduction in tumor burden of a predefined amount
measure: disease control rate (DCR)
time frame: approximately 2 years
description: the total proportion of patients who demonstrate a response to treatment
measure: Quality of life (QoL)
time frame: approximately 2 years
description: As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
arm group label: experimental group
arm group type: Experimental
description: apatinib 500 mg p.o. once daily
arm group label: control group
arm group type: Placebo Comparator
description: placebo p.o. once daily
intervention type: Drug
intervention name: apatinib
description: Patients in experimental group will take 500mg apatinib daily orally，and patients in control group will take placebo
arm group label: experimental group
intervention type: Drug
intervention name: Placebos
description: Physical properties of placebos are consistent with apatinib
arm group label: control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Mei Kai, Ph.D
phone: 18111277629
email: 250450418@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sichuan Cancer Hospital and Research Institute
investigator full name: Mei Kai
investigator title: associate senior doctor
mesh term: Ovarian Neoplasms
mesh term: Apatinib
sharing ipd: Undecided