<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/NCT03002805</url>
  </required_header>
  <id_info>
    <org_study_id>STS-1701</org_study_id>
    <nct_id>NCT03002805</nct_id>
  </id_info>
  <brief_title>CBT-1® in Combination With Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin</brief_title>
  <official_title>A Phase I Trial of CBT-1® in Combination With Doxorubicin in Patients With Locally Advanced or Metastatic, Unresectable Sarcomas Previously to Have Progressed on 150 mg/m2 or Less of Doxorubicin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CBA Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CBA Research</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the combination of CBT-1® and doxorubicin for the treatment of&#xD;
      metastatic, unresectable sarcoma in patients who have progressed after treatment with&#xD;
      150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day&#xD;
      cycle, as well as doxorubicin on days 5 and 6.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 29, 2018</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>Phase 1</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>Maximum tolerated dose of CBT-1® when combined with doxorubicin</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recommended phase 2 dose (RP2D) of CBT-1® when combined with doxorubicin</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR) of CBT-1® when combined with doxorubicin</measure>
    <time_frame>week 12</time_frame>
    <description>DCR = Overall Response Rate [ORR = Complete Response + Partial Response] + Stable Disease by RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlation of DCR, ORR and PFS to disease subtype</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Correlation of P-gp expression at baseline to P-gp expression after treatment</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Correlation of tumor response to P-gp inhibition by CBT-1®</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Presence of CBT-1® in tumor tissue</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Sarcoma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CBT-1®</intervention_name>
    <description>CBT-1®, oral, on days 1-7 of each cycle 21-day cycle. Participants will be assigned to dose level of CBT-1®:&#xD;
Dose level 1 - 50 mg/m2/day Dose level 2 - 100 mg/m2/day Dose level 3 - 150 mg/m2/day Dose level 4 - 200 mg/m2/day Dose level 5 - 250 mg/m2/day Dose level 6 - 300 mg/m2/day doxorubicin, 37.5 mg/m2, IV, on days 5 and 6 of each cycle Study treatment discontinued after 450 mg/m2 lifetime cumulative dose of doxorubicin reached or after 4-5 cycles completed.</description>
    <other_name>doxorubicin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Locally advanced or metastatic, unresectable sarcoma that has progressed after&#xD;
             treatment with 150 mg/m2 or less of doxorubicin or anthracycline equivalent&#xD;
&#xD;
          -  Measurable disease by RECIST 1.1&#xD;
&#xD;
          -  ECOG performance status of ≤ 1&#xD;
&#xD;
          -  Life expectancy of &gt; 3 months&#xD;
&#xD;
          -  Able to swallow pills&#xD;
&#xD;
          -  Adequate bone marrow and organ function as defined as:&#xD;
&#xD;
          -  Hemoglobin &gt; 9 g/dl&#xD;
&#xD;
          -  Absolute neutrophil count ≥ 1,500/mcL&#xD;
&#xD;
          -  Platelets ≥ 100,000/mcL&#xD;
&#xD;
          -  Total bilirubin &lt; 1.5 X ULN&#xD;
&#xD;
          -  AST(SGOT)/ALT(SGPT) ≤3 X ULN (including patients with liver metastases)&#xD;
&#xD;
          -  Creatinine &lt;1.5 X ULN&#xD;
&#xD;
          -  Cardiac ejection fraction &gt;50% (by echocardiogram or MUGA) within 15 days of&#xD;
             enrollment&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum or urine pregnancy test&#xD;
             within 7 days prior to enrollment.&#xD;
&#xD;
          -  Participants must be willing and able to comply with the study scheduled visits,&#xD;
             laboratory tests, and other procedures outlined in the protocol.&#xD;
&#xD;
          -  Pre-menopausal women must have a negative pregnancy test before study entry. Both&#xD;
             women and men must agree to use a medically acceptable method of contraception&#xD;
             throughout the treatment period and for at least six weeks after treatment&#xD;
             discontinuation. Acceptable methods of contraception include intrauterine device&#xD;
             (IUD), oral contraceptive, subdermal implant, double barrier and/or complete&#xD;
             abstinence (non-periodic).&#xD;
&#xD;
          -  Washout period prior to Day 1 Cycle 1:&#xD;
&#xD;
          -  3 weeks since last chemotherapy or therapeutic radiation therapy&#xD;
&#xD;
          -  4 weeks or 3 half-lives since prior antibody-based therapy, whichever is shorter&#xD;
&#xD;
          -  2 weeks since any oral anti-neoplastic or oral investigational agent&#xD;
&#xD;
          -  Resolution of treatment-related toxicity to &lt; grade 1; alopecia and cutaneous toxicity&#xD;
             are allowed &lt; grade 2&#xD;
&#xD;
          -  &gt;1 week since palliative RT&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior exposure to CBT-1&#xD;
&#xD;
          -  Previously untreated sarcomas&#xD;
&#xD;
          -  Low-grade sarcomas as well as alveolar soft parts sarcoma, clear cell sarcoma,&#xD;
             extraskeletal myxoid chondrosarcoma, well-differentiated liposarcoma, gastrointestinal&#xD;
             stromal tumor, chordoma&#xD;
&#xD;
          -  Participants receiving other investigational agents&#xD;
&#xD;
          -  Participants with known uncontrolled brain metastases&#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, chronic indwelling drains, history of interstitial pneumonitis or&#xD;
             pulmonary fibrosis or psychiatric illness/social situations that would limit&#xD;
             compliance with study requirements&#xD;
&#xD;
          -  Actively breastfeeding women unless it is interrupted during treatment and at least 6&#xD;
             weeks after treatment discontinuation&#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_contact>
    <last_name>Beth Gudeman</last_name>
    <phone>859-266-5757</phone>
    <email>bethg@cba-1.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Beth Gudeman</last_name>
    <phone>859-227-0699</phone>
    <email>bethg@cba-1.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sarcoma Oncology Research Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victoria Chua-Alcala</last_name>
      <phone>310-552-9999</phone>
      <email>vchua@sarcomaoncololgy.com</email>
    </contact>
    <investigator>
      <last_name>Sant P. Chawla, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherry Cook, RN</last_name>
      <phone>904-953-3321</phone>
      <email>cook.sherry1@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Steven Attia, D.O.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Anderson, RN</last_name>
      <phone>617-643-2427</phone>
      <email>banderson15@partners.org</email>
    </contact>
    <investigator>
      <last_name>Gregory Cote, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Research Nursing</last_name>
      <phone>617-632-5204</phone>
    </contact>
    <investigator>
      <last_name>Katherine Thornton, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Burgess, M.D.</last_name>
      <phone>412-692-4724</phone>
      <email>burgessma@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Melissa Burgess, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roxanne Moore</last_name>
      <phone>206-606-6425</phone>
      <email>romoore@seattlecca.org</email>
    </contact>
    <investigator>
      <last_name>Lee Cranmer, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>August 16, 2019</last_update_submitted>
  <last_update_submitted_qc>August 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase I</keyword>
  <keyword>CBT-1®</keyword>
  <keyword>Doxorubicin</keyword>
  <keyword>Sarcoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxorubicin</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/NCT03002805
org study id: STS-1701
nct id: NCT03002805
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates the combination of CBT-1® and doxorubicin for the treatment of
      metastatic, unresectable sarcoma in patients who have progressed after treatment with
      150mg/m2 or less of doxorubicin. Participants will receive CBT-1® on days 1-7 of each 21-day
      cycle, as well as doxorubicin on days 5 and 6.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose of CBT-1® when combined with doxorubicin
time frame: 3 years
measure: Recommended phase 2 dose (RP2D) of CBT-1® when combined with doxorubicin
time frame: 3 years
measure: Disease Control Rate (DCR) of CBT-1® when combined with doxorubicin
time frame: week 12
description: DCR = Overall Response Rate [ORR = Complete Response + Partial Response] + Stable Disease by RECIST 1.1
measure: Overall Response Rate
time frame: 3 years
measure: Correlation of DCR, ORR and PFS to disease subtype
time frame: 3 years
measure: Correlation of P-gp expression at baseline to P-gp expression after treatment
time frame: 3 years
measure: Correlation of tumor response to P-gp inhibition by CBT-1®
time frame: 3 years
measure: Presence of CBT-1® in tumor tissue
time frame: 3 years
intervention type: Drug
intervention name: CBT-1®
description: CBT-1®, oral, on days 1-7 of each cycle 21-day cycle. Participants will be assigned to dose level of CBT-1®:
Dose level 1 - 50 mg/m2/day Dose level 2 - 100 mg/m2/day Dose level 3 - 150 mg/m2/day Dose level 4 - 200 mg/m2/day Dose level 5 - 250 mg/m2/day Dose level 6 - 300 mg/m2/day doxorubicin, 37.5 mg/m2, IV, on days 5 and 6 of each cycle Study treatment discontinued after 450 mg/m2 lifetime cumulative dose of doxorubicin reached or after 4-5 cycles completed.
other name: doxorubicin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Beth Gudeman
phone: 859-266-5757
email: bethg@cba-1.com
last name: Beth Gudeman
phone: 859-227-0699
email: bethg@cba-1.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Sarcoma
mesh term: Doxorubicin