<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/NCT01677455</url>
  </required_header>
  <id_info>
    <org_study_id>9090-11</org_study_id>
    <nct_id>NCT01677455</nct_id>
  </id_info>
  <brief_title>An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer</brief_title>
  <acronym>Enchant</acronym>
  <official_title>An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Synta Pharmaceuticals Corp.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Synta Pharmaceuticals Corp.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if ganetespib (STA-9090) is effective in the&#xD;
      treatment of patients with HER2+ or triple negative breast cancer who have not received prior&#xD;
      systemic treatment in the metastatic setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>Week 12</time_frame>
    <description>Objective response rate is based on RECIST criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response and progression free survival</measure>
    <time_frame>Every six weeks until progression</time_frame>
    <description>Progressive disease based on RECIST criteria. CT scans at week 6, week 12 and every 6 weeks thereafter for the duration of the study.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Breast Cancer</condition>
  <condition>HER-2 Positive Breast Cancer</condition>
  <condition>Triple Negative Breast Cancer</condition>
  <condition>ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment</condition>
  <arm_group>
    <arm_group_label>HER2+ breast cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Triple negative breast cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Closed to enrollment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ER/PR+ Refractory to Prior Hormonal Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ganetespib</intervention_name>
    <description>Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.</description>
    <arm_group_label>ER/PR+ Refractory to Prior Hormonal Treatment</arm_group_label>
    <arm_group_label>HER2+ breast cancer</arm_group_label>
    <arm_group_label>Triple negative breast cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically confirmed diagnosis of invasive breast cancer.&#xD;
&#xD;
          -  Stage IV disease.&#xD;
&#xD;
          -  Documented HER2 and hormonal receptor status per protocol, ER/PR+ patients must be&#xD;
             refractory to at least one prior hormonal treatment.&#xD;
&#xD;
          -  ECOG Performance status 0-1.&#xD;
&#xD;
          -  Measurable disease per RECIST (1.1).&#xD;
&#xD;
          -  Adequate hematological function per protocol.&#xD;
&#xD;
          -  Adequate hepatic function per protocol.&#xD;
&#xD;
          -  Adequate renal function per protocol.&#xD;
&#xD;
          -  Negative serum pregnancy test at study entry for patients of childbearing potential.&#xD;
&#xD;
          -  Ability to understand and sign written consent and to comply with the study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of active or untreated CNS metastases as determined by MRI/CT scan performed&#xD;
             during screening.&#xD;
&#xD;
          -  Active malignancies other than MBC within the last 5 years except adequately treated&#xD;
             in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin.&#xD;
&#xD;
          -  Bone as the only site of metastatic disease from breast cancer.&#xD;
&#xD;
          -  Prior radiotherapy to the only area of measurable disease. NOTE: Radiotherapy to a&#xD;
             limited area other than the sole site of measurable disease is allowed, if received&#xD;
             prior to initiation of ganetespib treatment. Patients must have completed treatment&#xD;
             and recovered from all acute treatment-related toxicities prior to administration of&#xD;
             first dose of ganetespib.&#xD;
&#xD;
          -  Pregnancy or lactation.&#xD;
&#xD;
          -  Known serious cardiac illness.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness per protocol.&#xD;
&#xD;
          -  Other severe acute or chronic medical condition or abnormality that may increase the&#xD;
             risk associated with study participation or study drug administration, or may&#xD;
             interfere with the interpretation of study results, or that in the judgment of the&#xD;
             investigator would make the patient inappropriate for entry into the study.&#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>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Altanta</city>
        <state>Georgia</state>
        <zip>30341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111-2497</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceutical Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Cordoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Rosario Santa Fe</city>
        <zip>S2000KZE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Brussels</city>
        <zip>B-1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceutical Investigative Site</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceutical Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-GU</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Jongno-Gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmacuetical Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Seodaemun-GU</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-Gu</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Lima</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceutical Investigative Site</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceutical Investigative Site</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceutical Investigative Site</name>
      <address>
        <city>Nottingham</city>
        <zip>NG51PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceuticals Investigative Site</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synta Pharmaceutical Investigative Site</name>
      <address>
        <city>Peterborough</city>
        <zip>PE3 9GZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Korea, Republic of</country>
    <country>Peru</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 9, 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>November 4, 2015</last_update_submitted>
  <last_update_submitted_qc>November 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hsp90 inhibitor</keyword>
  <keyword>ganetespib</keyword>
  <keyword>STA 9090</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_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/NCT01677455
org study id: 9090-11
nct id: NCT01677455
lead sponsor: 
has dmc: No
The purpose of this study is to determine if ganetespib (STA-9090) is effective in the
      treatment of patients with HER2+ or triple negative breast cancer who have not received prior
      systemic treatment in the metastatic setting.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate
time frame: Week 12
description: Objective response rate is based on RECIST criteria
measure: Duration of response and progression free survival
time frame: Every six weeks until progression
description: Progressive disease based on RECIST criteria. CT scans at week 6, week 12 and every 6 weeks thereafter for the duration of the study.
arm group label: HER2+ breast cancer
arm group type: Experimental
arm group label: Triple negative breast cancer
arm group type: Experimental
description: Closed to enrollment
arm group label: ER/PR+ Refractory to Prior Hormonal Treatment
arm group type: Experimental
intervention type: Drug
intervention name: ganetespib
description: Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
arm group label: ER/PR+ Refractory to Prior Hormonal Treatment
arm group label: HER2+ breast cancer
arm group label: Triple negative breast cancer
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Belgium
country: Brazil
country: Korea, Republic of
country: Peru
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms