<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/NCT03023319</url>
  </required_header>
  <id_info>
    <org_study_id>EXP-16-01</org_study_id>
    <nct_id>NCT03023319</nct_id>
  </id_info>
  <brief_title>Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors</brief_title>
  <official_title>Phase I Study of the Non-receptor Kinase Inhibitor Bosutinib in Combination With Pemetrexed in Patients With Selected Metastatic Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nagla Abdel Karim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Augusta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in&#xD;
      combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that&#xD;
      can be given without causing severe side effects. This study will also test the safety of&#xD;
      this combination and see what effects (good or bad) it has on participants and their cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2019</start_date>
  <completion_date type="Actual">May 10, 2022</completion_date>
  <primary_completion_date type="Actual">May 10, 2022</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>Dose-limiting toxicity of the combination of bosutinib and pemetrexed</measure>
    <time_frame>21 days</time_frame>
    <description>CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum tolerated dose of the combination of bosutinib and pemetrexed</measure>
    <time_frame>completion of dose escalation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events of the combination of bosutinib and pemetrexed</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-tumor response rate</measure>
    <time_frame>6 and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>6 and 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <condition>Mesothelioma</condition>
  <condition>Bladder Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Peritoneal Cancer</condition>
  <condition>Thymoma</condition>
  <condition>Thymus Cancer</condition>
  <condition>Uterine Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Bosutinib and Pemetrexed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bosutinib and pemetrexed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bosutinib</intervention_name>
    <description>100mg daily for 4 cycles (21 days per cycle)</description>
    <arm_group_label>Bosutinib and Pemetrexed</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>500 mg/m2 every 21 days for 4 cycles</description>
    <arm_group_label>Bosutinib and Pemetrexed</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically or cytologically proven advanced, metastatic non-squamous non-small&#xD;
             cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian&#xD;
             cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical&#xD;
             cancer.&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
          -  Life expectancy of greater than 3 months.&#xD;
&#xD;
          -  Ability to take folic acid, vitamin B12, and dexamethasone according to protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Untreated or symptomatic brain metastases.&#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>Nagla Karim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Augusta University Georgia Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Augusta University Georgia Cancer Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>June 10, 2022</last_update_submitted>
  <last_update_submitted_qc>June 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Augusta University</investigator_affiliation>
    <investigator_full_name>Nagla Abdel Karim</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Mesothelioma</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Thymoma</mesh_term>
    <mesh_term>Thymus Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pemetrexed</mesh_term>
  </intervention_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/NCT03023319
org study id: EXP-16-01
nct id: NCT03023319
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in
      combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that
      can be given without causing severe side effects. This study will also test the safety of
      this combination and see what effects (good or bad) it has on participants and their cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose-limiting toxicity of the combination of bosutinib and pemetrexed
time frame: 21 days
description: CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting.
measure: Maximum tolerated dose of the combination of bosutinib and pemetrexed
time frame: completion of dose escalation
measure: Adverse events of the combination of bosutinib and pemetrexed
time frame: 16 weeks
measure: Anti-tumor response rate
time frame: 6 and 12 weeks
measure: Progression-free survival
time frame: 6 and 12 weeks
arm group label: Bosutinib and Pemetrexed
arm group type: Experimental
description: Bosutinib and pemetrexed
intervention type: Drug
intervention name: Bosutinib
description: 100mg daily for 4 cycles (21 days per cycle)
arm group label: Bosutinib and Pemetrexed
intervention type: Drug
intervention name: Pemetrexed
description: 500 mg/m2 every 21 days for 4 cycles
arm group label: Bosutinib and Pemetrexed
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nagla Karim, MD
role: Principal Investigator
affiliation: Augusta University Georgia Cancer Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Augusta University
investigator full name: Nagla Abdel Karim
investigator title: Associate Professor of Medicine
mesh term: Uterine Cervical Neoplasms
mesh term: Mesothelioma
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Thymoma
mesh term: Thymus Neoplasms
mesh term: Pemetrexed
sharing ipd: No