<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/NCT04446793</url>
  </required_header>
  <id_info>
    <org_study_id>CRDF-01E</org_study_id>
    <nct_id>NCT04446793</nct_id>
  </id_info>
  <brief_title>Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer</brief_title>
  <official_title>An Expanded Access Program of Onvansertib in Combination With FOLFIRI and Bevacizumab for the Second-Line Treatment of Patients With KRAS-Mutated Metastatic Colorectal Cancer (mCRC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiff Oncology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiff Oncology</source>
  <brief_summary>
    <textblock>
      This is an expanded access program for eligible participants designed to provide access to&#xD;
      onvansertib in combination with FOLFIRI and bevacizumab.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <expanded_access_info>
    <expanded_access_type_intermediate>Yes</expanded_access_type_intermediate>
  </expanded_access_info>
  <condition>Metastatic Colorectal Cancer</condition>
  <condition>KRAS Gene Mutation</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Onvansertib</intervention_name>
    <description>15 mg/m^2 will be administered orally on Day 1 to Day 5 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.</description>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>5 mg/kg will be administered intravenously on Day 1 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.</description>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFIRI</intervention_name>
    <description>FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil [5-FU], and 2400 mg/m^2 continuous intravenous infusion 5-FU over 46 hours) will be administered intravenously on Day 1 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is NOT eligible for other clinical trials currently open in the region&#xD;
&#xD;
          -  Participant has failed or progressed on standard of care systemic therapy&#xD;
&#xD;
          -  FOLFIRI (with or without 5FU bolus and continuous infusion)/bevacizumab plus&#xD;
             onvansertib is appropriate for the participant as determined by the treating&#xD;
             physician, including participants who have previously been treated with FOLFIRI&#xD;
&#xD;
          -  Histologically confirmed metastatic and unresectable CRC with a confirmed KRAS&#xD;
             mutation&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Women of Child-bearing Potential&#xD;
&#xD;
          -  Women of child-bearing potential (WOCBP) must agree to use method(s) of contraception&#xD;
&#xD;
          -  WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L&#xD;
             or equivalent units of human chorionic gonadotropin) within 24 hours prior to the&#xD;
             start of onvansertib treatment&#xD;
&#xD;
          -  If sexually active, the participant must agree to use contraception considered&#xD;
             adequate and appropriate by the treating physician during the period of onvansertib&#xD;
             administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has not recovered from minor or major surgery and less than 6 weeks out&#xD;
             from major surgery&#xD;
&#xD;
          -  Participant has active Hepatitis B or C infection&#xD;
&#xD;
          -  Participant has a known history of testing positive for human immunodeficiency virus&#xD;
             or having been diagnosed with acquired immunodeficiency syndrome&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, clinically significant non-healing or healing wounds, symptomatic&#xD;
             congestive heart failure Class II or higher according to the New York Heart&#xD;
             Association Functional Classification, unstable angina pectoris, significant pulmonary&#xD;
             disease (shortness of breath at rest or mild exertion), that would limit compliance&#xD;
             with study requirements&#xD;
&#xD;
          -  Abnormal glucuronidation of bilirubin, known Gilbert's syndrome&#xD;
&#xD;
          -  Participants with any other serious or uncontrolled medical disorder, active&#xD;
             infection, physical exam finding, laboratory finding, altered mental status, or&#xD;
             psychiatric condition that, in the opinion of the treating physician, would&#xD;
             substantially increase risk to their well-being&#xD;
&#xD;
          -  Any condition that, in the opinion of the treating physician, would substantially&#xD;
             increase risk to their well-being&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>January 18, 2021</last_update_submitted>
  <last_update_submitted_qc>January 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Cancer</keyword>
  <keyword>KRAS-Mutation</keyword>
  <keyword>Onvansertib</keyword>
  <keyword>PCM-075</keyword>
  <keyword>FOLFIRI</keyword>
  <keyword>Irinotecan</keyword>
  <keyword>5-Fluoruracil</keyword>
  <keyword>Bevacizumab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Onvansertib</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/NCT04446793
org study id: CRDF-01E
nct id: NCT04446793
lead sponsor: 
This is an expanded access program for eligible participants designed to provide access to
      onvansertib in combination with FOLFIRI and bevacizumab.
expanded access type intermediate: Yes
intervention type: Drug
intervention name: Onvansertib
description: 15 mg/m^2 will be administered orally on Day 1 to Day 5 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.
intervention type: Biological
intervention name: Bevacizumab
description: 5 mg/kg will be administered intravenously on Day 1 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.
intervention type: Drug
intervention name: FOLFIRI
description: FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil [5-FU], and 2400 mg/m^2 continuous intravenous infusion 5-FU over 46 hours) will be administered intravenously on Day 1 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Bevacizumab
mesh term: Onvansertib