<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/NCT03030287</url>
  </required_header>
  <id_info>
    <org_study_id>B83-002</org_study_id>
    <nct_id>NCT03030287</nct_id>
  </id_info>
  <brief_title>A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer</brief_title>
  <official_title>A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OncoMed Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mereo BioPharma</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the efficacy and safety of an experimental drug,&#xD;
      OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal&#xD;
      antibody and was developed to target cancer stem cells. Based on preclinical studies, it is&#xD;
      believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the&#xD;
      productive growth of new blood vessels, which tumors need to grow and spread.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus&#xD;
      paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in&#xD;
      combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal&#xD;
      or fallopian tube cancer. This study consists of a screening period, a treatment period and a&#xD;
      post-treatment follow up period in which patients will be followed for survival for&#xD;
      approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and&#xD;
      an expansion phase.&#xD;
&#xD;
      Approximately 30 patients will be enrolled in this study at approximately 5 study centers in&#xD;
      the United States (U.S)..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">April 2020</completion_date>
  <primary_completion_date type="Actual">April 2020</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>Incidence of dose limiting toxicities (DLT)</measure>
    <time_frame>Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).</time_frame>
    <description>The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in subjects treated with OMP-305B83 in combination with Paclitaxel</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of OMP-30B583 in combination with Paclitaxel will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with Paclitaxel</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate assessed by RECIST criteria 1.1</measure>
    <time_frame>At 56 day intervals while on treatment, through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate assessed by CA-125 criteria</measure>
    <time_frame>At 28 day intervals while on treatment, through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Cancer Ovaries</condition>
  <condition>Cancer Peritoneal</condition>
  <condition>Cancer, Fallopian Tube</condition>
  <arm_group>
    <arm_group_label>OMP-305B83 plus paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OMP-305B83</intervention_name>
    <description>intravenous (in the vein) infusion</description>
    <arm_group_label>OMP-305B83 plus paclitaxel</arm_group_label>
    <other_name>bispecific monoclonal antibody</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>administered intravenously</description>
    <arm_group_label>OMP-305B83 plus paclitaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer&#xD;
&#xD;
          2. Measureable disease per response evaluation criteria (RECIST) v1.1&#xD;
&#xD;
          3. Prior bevacizumab&#xD;
&#xD;
          4. Age &gt; or = 21 years&#xD;
&#xD;
          5. Adequate organ and marrow function&#xD;
&#xD;
          6. For women of childbearing potential and men with partners of childbearing potential,&#xD;
             agreement (by patient and/or partner) to use two effective forms of contraception from&#xD;
             study entry through at least 6 months after the termination visit.&#xD;
&#xD;
          7. Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic&#xD;
             therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless&#xD;
             administered more than 2 years prior to enrollment, unless part of an upfront&#xD;
             treatment strategy.&#xD;
&#xD;
          2. History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess,&#xD;
             clinical signs or symptoms of gastrointestinaI obstruction or other known clinically&#xD;
             signification gastrointestinal disease.&#xD;
&#xD;
          3. Subjects with brain metastases&#xD;
&#xD;
          4. Subjects with leptomeningial disease or neoplasms in the last 5 years&#xD;
&#xD;
          5. Blood pressure &gt;140/80&#xD;
&#xD;
          6. Significant intercurrent illness that will limit the patient's ability to participate&#xD;
             in the study&#xD;
&#xD;
          7. Subjects with known metastases that are currently involving the lumen of the&#xD;
             gastrointestinal tract.&#xD;
&#xD;
          8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days&#xD;
             prior to enrollment, or anticipation of need for major surgical procedure during the&#xD;
             course of the study&#xD;
&#xD;
          9. Pregnant or nursing women&#xD;
&#xD;
         10. New York Heart Association Classification II, III, or IV&#xD;
&#xD;
         11. Inability to comply with study and follow up procedure&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Colorado, Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center &amp; Research Institute, Inc. (Moffitt Cancer Center)</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Pennsylvania Health System</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas, MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 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>Fallopian Tube 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>Antibodies, Bispecific</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/NCT03030287
org study id: B83-002
nct id: NCT03030287
lead sponsor: 
The purpose of this study is to test the efficacy and safety of an experimental drug,
      OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal
      antibody and was developed to target cancer stem cells. Based on preclinical studies, it is
      believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the
      productive growth of new blood vessels, which tumors need to grow and spread.
This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus
      paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in
      combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal
      or fallopian tube cancer. This study consists of a screening period, a treatment period and a
      post-treatment follow up period in which patients will be followed for survival for
      approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and
      an expansion phase.

      Approximately 30 patients will be enrolled in this study at approximately 5 study centers in
      the United States (U.S)..
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of dose limiting toxicities (DLT)
time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
description: The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in subjects treated with OMP-305B83 in combination with Paclitaxel
measure: Safety of OMP-30B583 in combination with Paclitaxel will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.
time frame: Through study completion, an average of 6 months
measure: To assess Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with Paclitaxel
time frame: Through study completion, an average of 6 months
measure: Response Rate assessed by RECIST criteria 1.1
time frame: At 56 day intervals while on treatment, through study completion, an average of 6 months
measure: Response Rate assessed by CA-125 criteria
time frame: At 28 day intervals while on treatment, through study completion, an average of 6 months
measure: Progression Free Survival
time frame: Up to 5 years
arm group label: OMP-305B83 plus paclitaxel
arm group type: Experimental
intervention type: Drug
intervention name: OMP-305B83
description: intravenous (in the vein) infusion
arm group label: OMP-305B83 plus paclitaxel
other name: bispecific monoclonal antibody
intervention type: Drug
intervention name: Paclitaxel
description: administered intravenously
arm group label: OMP-305B83 plus paclitaxel
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fallopian Tube Neoplasms
mesh term: Paclitaxel
mesh term: Antibodies, Bispecific