<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/NCT01677390</url>
  </required_header>
  <id_info>
    <org_study_id>SGN75-002</org_study_id>
    <nct_id>NCT01677390</nct_id>
  </id_info>
  <brief_title>A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma</brief_title>
  <official_title>A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seagen Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seagen Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of&#xD;
      SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell&#xD;
      carcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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 adverse events and laboratory abnormalities</measure>
    <time_frame>Through 1 month post last dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best clinical response according to RECIST Version 1.1</measure>
    <time_frame>Through 1 month post last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>Until disease progression or start of new anticancer treatment, an expected average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Until death or study closure, an expected average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood concentrations of SGN-75 and metabolites</measure>
    <time_frame>Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of antitherapeutic antibodies</measure>
    <time_frame>Pre-dose in most cycles and 1 month post last dose</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SGN-75, everolimus</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SGN-75</intervention_name>
    <description>1-2 mg/kg IV every 21 days</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>everolimus</intervention_name>
    <description>10 mg PO daily</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression&#xD;
&#xD;
          -  Previously treated with at least 1 tyrosine kinase inhibitor (TKI)&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status 0 or 1&#xD;
&#xD;
          -  Adequate lung and renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with anti-CD70-directed therapy&#xD;
&#xD;
          -  Received more than one prior treatment with an mTOR inhibitor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elaina Gartner, MD</last_name>
    <role>Study Director</role>
    <affiliation>Seagen Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Cancer Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers - Midtown</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute / Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Lineberger Comprehensive Cancer Center / University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miriam Hospital, The</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02906</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance / University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109-1023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>January 24, 2014</last_update_submitted>
  <last_update_submitted_qc>January 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antibody-Drug Conjugate</keyword>
  <keyword>monomethylauristatin F</keyword>
  <keyword>Carcinoma, Renal Cell</keyword>
  <keyword>Antigens, CD70</keyword>
  <keyword>Drug Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</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/NCT01677390
org study id: SGN75-002
nct id: NCT01677390
lead sponsor: 
has dmc: No
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of
      SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell
      carcinoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events and laboratory abnormalities
time frame: Through 1 month post last dose
measure: Best clinical response according to RECIST Version 1.1
time frame: Through 1 month post last dose
measure: Progression-free survival
time frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months
measure: Overall survival
time frame: Until death or study closure, an expected average of 1 year
measure: Blood concentrations of SGN-75 and metabolites
time frame: Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose
measure: Incidence of antitherapeutic antibodies
time frame: Pre-dose in most cycles and 1 month post last dose
arm group label: Arm 1
arm group type: Experimental
description: SGN-75, everolimus
intervention type: Drug
intervention name: SGN-75
description: 1-2 mg/kg IV every 21 days
arm group label: Arm 1
intervention type: Drug
intervention name: everolimus
description: 10 mg PO daily
arm group label: Arm 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elaina Gartner, MD
role: Study Director
affiliation: Seagen Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Everolimus