<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/NCT01711970</url>
  </required_header>
  <id_info>
    <org_study_id>VB-111-157</org_study_id>
    <secondary_id>11-418</secondary_id>
    <nct_id>NCT01711970</nct_id>
    <nct_alias>NCT01801215</nct_alias>
  </id_info>
  <brief_title>A Phase I/II Trial of VB-111 and Paclitaxel for Recurrent Platinum-Resistant Müllerian Cancer</brief_title>
  <official_title>A Phase I/II Trial of Multiple Dose VB-111 and Weekly Paclitaxel for the Treatment of Recurrent Platinum-Resistant Müllerian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vascular Biogenics Ltd. operating as VBL Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vascular Biogenics Ltd. operating as VBL Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the&#xD;
      safety and tolerability of the combination of intravenous administration of VB-111 and&#xD;
      paclitaxel in patients with platinum resistant ovarian cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 3, 2017</completion_date>
  <primary_completion_date type="Actual">May 3, 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Define toxicities</measure>
    <time_frame>2 years</time_frame>
    <description>Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Platinum Resistant Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>VB-111</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <arm_group_label>VB-111</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt; 18&#xD;
&#xD;
          -  Histologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer, and&#xD;
             uterine papillary serous carcinomas (UPSC), and gynecologic malignant mixed müllerian&#xD;
             tumors (MMMTs).&#xD;
&#xD;
          -  Must have had prior platinum or platinum based therapy.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) status 0-1.&#xD;
&#xD;
          -  Platinum resistant or refractory disease within 6 months of completing or while&#xD;
             receiving a platinum and taxane containing regimen&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
          -  Adequate bone marrow and hematological function.&#xD;
&#xD;
          -  Must have recovered from acute toxicity from prior treatment&#xD;
&#xD;
          -  Prior treatment with an anti-angiogenic agent is not an exclusion criterion.&#xD;
&#xD;
          -  No prior GI perforation, or GI obstruction or involvement of the bowel on imaging&#xD;
&#xD;
          -  Known hypersensitivity to Cremophor EL. However, participants are eligible if they&#xD;
             have had a prior paclitaxel reaction, but subsequently tolerated the drug at&#xD;
             rechallenge.&#xD;
&#xD;
          -  No patients receiving other investigational therapy for the past 30 days before&#xD;
             dosing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 3 prior lines of chemotherapy for recurrent cancer.&#xD;
&#xD;
          -  History of other active malignancy, other than superficial basal cell and superficial&#xD;
             squamous cell, or carcinoma in situ of the cervix within last 2 years.&#xD;
&#xD;
          -  Life expectancy of less than 3 months&#xD;
&#xD;
          -  CTC Grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior&#xD;
             taxane exposure, such as diabetes.&#xD;
&#xD;
          -  Inadequately controlled hypertension or prior history of hypertensive crisis or&#xD;
             hypertensive encephalopathy.&#xD;
&#xD;
          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure.&#xD;
&#xD;
          -  History of myocardial infarction or unstable angina within 6 months prior to study Day&#xD;
             1.&#xD;
&#xD;
          -  History of stroke or transient ischemic attack within 6 months prior to Day 1.&#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 Day 1.&#xD;
&#xD;
          -  History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month&#xD;
             prior to Day 1.&#xD;
&#xD;
          -  Evidence of bleeding diathesis or significant coagulopathy (in the absence of&#xD;
             therapeutic anticoagulation).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>November 16, 2021</submitted>
    <returned>December 15, 2021</returned>
  </pending_results>
  <!-- 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/NCT01711970
org study id: VB-111-157
secondary id: 11-418
nct id: NCT01711970
nct alias: NCT01801215
lead sponsor: 
has dmc: Yes
This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the
      safety and tolerability of the combination of intravenous administration of VB-111 and
      paclitaxel in patients with platinum resistant ovarian cancer.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Define toxicities
time frame: 2 years
description: Define toxicities of a limited number of doses of combination VB-111 and weekly paclitaxel spanning anticipated effective doses.
arm group label: VB-111
arm group type: Experimental
intervention type: Drug
intervention name: Paclitaxel
arm group label: VB-111
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Paclitaxel
submitted: November 16, 2021
returned: December 15, 2021