<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/NCT01665937</url>
  </required_header>
  <id_info>
    <org_study_id>10-072</org_study_id>
    <nct_id>NCT01665937</nct_id>
  </id_info>
  <brief_title>STA-9090 in Patients With Advanced Hepatocellular Cancer</brief_title>
  <official_title>A Phase I Study of STA-9090 in Patients With Advanced Hepatocellular Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Synta Pharmaceuticals Corp.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      STA-9090 works by inhibiting the function of a protein in tumor cells called Hsp90. Hsp90 is&#xD;
      thought to play a role in tumor growth. By interfering with this protein's function, STA-9090&#xD;
      may help kill tumor cells. This drug has been used in other research studies and information&#xD;
      from those studies suggests that this agent may help to slow tumor growth in HCC.&#xD;
&#xD;
      The purpose of this research study is to find the highest dose of STA-9090 that can safely be&#xD;
      given to participants with advanced HCC. The investigators will also get more information&#xD;
      about the safety of STA-9090 and perform tests to learn more about how STA-9090 affects the&#xD;
      body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study treatment is given in 4-week time periods called cycles. Patients will receive ST-9090&#xD;
      once weekly for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090&#xD;
      will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or&#xD;
      tube) placed in the vein. Each infusion will last about 60 minutes.&#xD;
&#xD;
      During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to thirty&#xD;
      days after the last dose, patients will return for a physical exam, blood tests, urine test,&#xD;
      EKG, and CT or MRI of chest and abdomen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">July 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>Phase 2 dose of STA 9090 given once weekly in patients with advanced hepatocellular carcinoma</measure>
    <time_frame>3 years</time_frame>
    <description>Dose escalation/de-escalation study will be performed in order to determine the Phase 2 dose of STA-9090 given once weekly in patients with advanced hepatocellular carcinoma. The dose limiting toxicities will be determined at each dose level.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events when treated with STA 9090 for advanced hepatocellular carcinoma</measure>
    <time_frame>3 years</time_frame>
    <description>To assess the safety and tolerability of STA9090 in patients with advanced hepatocellular carcinoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median time to progression (TTP)</measure>
    <time_frame>3 years</time_frame>
    <description>To determine median time to progression (TTP) for patients treated at recommended Phase 2 dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median progression-free survival (PFS)</measure>
    <time_frame>3 years</time_frame>
    <description>To determine median progression-free survival (PFS) for patients treated at recommended Phase 2 dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>3 years</time_frame>
    <description>To determine objective tumor response rate using RECIST criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 years</time_frame>
    <description>To determine overall survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Hepatocellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>STA-9090</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving STA-9090</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>STA-9090</intervention_name>
    <description>IV one time weekly for 3 weeks in 4 week cycles. Study treatment is given in 4-week time periods called cycles. Patients will receive STA-9090 for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090 will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or tube) placed in the vein. Each infusion will last about 60 minutes.&#xD;
During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to thirty days after the last dose, patients will return for a physical exam, blood tests, urine test, EKG, and CT or MRI of chest and abdomen.</description>
    <arm_group_label>STA-9090</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed hepatocellular carcinoma&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
          -  Life expectancy greater than 3 months&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
          -  BCLC Stage C disease&#xD;
&#xD;
          -  Lab values must be within limits outlined in protocol&#xD;
&#xD;
          -  Child-Pugh score &lt;/= 6&#xD;
&#xD;
          -  CLIP score 0-3&#xD;
&#xD;
          -  Must agree to use adequate contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chemotherapy or radiotherapy within 4 weeks prior to entering study or not recovered&#xD;
             from adverse events due to agents administered more than 4 weeks earlier&#xD;
&#xD;
          -  Receiving any other investigational agent&#xD;
&#xD;
          -  Known brain metastases unless treated and radiographically and clinically stable&#xD;
             without steroid or anticonvulsant medications for at least 4 weeks prior to first dose&#xD;
             of STA-9090&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to STA-9090&#xD;
&#xD;
          -  Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable&#xD;
             disease&#xD;
&#xD;
          -  Major surgery within 4 weeks prior to first dose of STA-9090&#xD;
&#xD;
          -  Poor venous access for study drug administration or would require a peripheral or&#xD;
             central indwelling catheter for study drug administration&#xD;
&#xD;
          -  History of severe allergic or hypersensitivity reactions to excipients (e.g.,&#xD;
             Polyethylene glycol [PE] 300 and Polysorbate 80)&#xD;
&#xD;
          -  Baseline QTc &gt; 450 msec or previous history of QT prolongation while taking other&#xD;
             medications&#xD;
&#xD;
          -  Ventricular ejection fraction &lt;/= 55% at baseline&#xD;
&#xD;
          -  Treatment with chronic immunosuppressants&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  History of a different malignancy unless disease-free for at least 5 years and deemed&#xD;
             by the investigator to be at low risk for recurrence.&#xD;
&#xD;
          -  HIV-positive individuals on combination antiretroviral therapy&#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>Andrew Zhu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>April 27, 2010</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>April 23, 2018</last_update_submitted>
  <last_update_submitted_qc>April 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Andrew X. Zhu, MD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>liver cancer</keyword>
  <keyword>advanced liver cancer</keyword>
  <keyword>advanced hepatocellular cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01665937
org study id: 10-072
nct id: NCT01665937
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
STA-9090 works by inhibiting the function of a protein in tumor cells called Hsp90. Hsp90 is
      thought to play a role in tumor growth. By interfering with this protein's function, STA-9090
      may help kill tumor cells. This drug has been used in other research studies and information
      from those studies suggests that this agent may help to slow tumor growth in HCC.

      The purpose of this research study is to find the highest dose of STA-9090 that can safely be
      given to participants with advanced HCC. The investigators will also get more information
      about the safety of STA-9090 and perform tests to learn more about how STA-9090 affects the
      body.
Study treatment is given in 4-week time periods called cycles. Patients will receive ST-9090
      once weekly for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090
      will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or
      tube) placed in the vein. Each infusion will last about 60 minutes.

      During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to thirty
      days after the last dose, patients will return for a physical exam, blood tests, urine test,
      EKG, and CT or MRI of chest and abdomen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 2 dose of STA 9090 given once weekly in patients with advanced hepatocellular carcinoma
time frame: 3 years
description: Dose escalation/de-escalation study will be performed in order to determine the Phase 2 dose of STA-9090 given once weekly in patients with advanced hepatocellular carcinoma. The dose limiting toxicities will be determined at each dose level.
measure: Number of patients with adverse events when treated with STA 9090 for advanced hepatocellular carcinoma
time frame: 3 years
description: To assess the safety and tolerability of STA9090 in patients with advanced hepatocellular carcinoma.
measure: Median time to progression (TTP)
time frame: 3 years
description: To determine median time to progression (TTP) for patients treated at recommended Phase 2 dose.
measure: Median progression-free survival (PFS)
time frame: 3 years
description: To determine median progression-free survival (PFS) for patients treated at recommended Phase 2 dose.
measure: Response Rate
time frame: 3 years
description: To determine objective tumor response rate using RECIST criteria
measure: Overall Survival
time frame: 3 years
description: To determine overall survival
arm group label: STA-9090
arm group type: Experimental
description: Patients receiving STA-9090
intervention type: Drug
intervention name: STA-9090
description: IV one time weekly for 3 weeks in 4 week cycles. Study treatment is given in 4-week time periods called cycles. Patients will receive STA-9090 for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090 will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or tube) placed in the vein. Each infusion will last about 60 minutes.
During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to thirty days after the last dose, patients will return for a physical exam, blood tests, urine test, EKG, and CT or MRI of chest and abdomen.
arm group label: STA-9090
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Zhu, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Andrew X. Zhu, MD
investigator title: MD, PhD
mesh term: Carcinoma
mesh term: Carcinoma, Hepatocellular
sharing ipd: No