<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/NCT02191761</url>
  </required_header>
  <id_info>
    <org_study_id>SM04755-ONC-01</org_study_id>
    <nct_id>NCT02191761</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer</brief_title>
  <official_title>Phase1, Open-Label, Dose Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biosplice Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biosplice Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, multi-center, dose escalation study in adult subjects with advanced&#xD;
      colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety,&#xD;
      tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally.&#xD;
      Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2014</start_date>
  <completion_date type="Actual">May 20, 2015</completion_date>
  <primary_completion_date type="Actual">May 20, 2015</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>Determine the MTD</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration (AUC) Versus Time Curve of SM04755</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of SM04755</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half Life of SM04755</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution of SM04755</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation ratio of SM04755</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Clearance of SM04755 after oral administration</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Gastric Cancer</condition>
  <condition>Hepatic Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>SM04755</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SM04755</intervention_name>
    <description>Escalating Doses</description>
    <arm_group_label>SM04755</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer&#xD;
&#xD;
          -  Subjects must have recovered from all toxicity associated with previous chemotherapy,&#xD;
             targeted therapy, or radiotherapy&#xD;
&#xD;
          -  Subjects must meet certain laboratory criteria&#xD;
&#xD;
          -  Expected survival &gt; 3months&#xD;
&#xD;
          -  Subjects must have no uncontrolled intercurrent illness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or lactating, or who are of childbearing potential , and men&#xD;
             who do not use a barrier method&#xD;
&#xD;
          -  Subjects with significant cardiac issues&#xD;
&#xD;
          -  Subjects using certain medications&#xD;
&#xD;
          -  Subjects with certain medical conditions&#xD;
&#xD;
          -  Subjects with brain metastasis&#xD;
&#xD;
          -  Subjects who have recently been enrolled in other experimental clinical trials of&#xD;
             investigational agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>September 5, 2018</last_update_submitted>
  <last_update_submitted_qc>September 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Liver 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/NCT02191761
org study id: SM04755-ONC-01
nct id: NCT02191761
lead sponsor: 
has dmc: No
This is an open-label, multi-center, dose escalation study in adult subjects with advanced
      colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety,
      tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally.
      Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine the MTD
time frame: 28 days
measure: Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings
time frame: 28 days
measure: Area under the plasma concentration (AUC) Versus Time Curve of SM04755
time frame: 30 days
measure: Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: 8 weeks
measure: Maximum Observed Plasma Concentration (Cmax) of SM04755
time frame: 30 Days
measure: Half Life of SM04755
time frame: 30 Days
measure: Volume of Distribution of SM04755
time frame: 30 Days
measure: Time to maximum plasma concentration
time frame: 30 Days
measure: Accumulation ratio of SM04755
time frame: 30 Days
measure: Total Clearance of SM04755 after oral administration
time frame: 30 days
arm group label: SM04755
arm group type: Experimental
intervention type: Drug
intervention name: SM04755
description: Escalating Doses
arm group label: SM04755
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Liver Neoplasms