<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/NCT02216487</url>
  </required_header>
  <id_info>
    <org_study_id>ACO-004</org_study_id>
    <nct_id>NCT02216487</nct_id>
  </id_info>
  <brief_title>Trial of FOLF(HA)Iri With Cetuximab in mCRC</brief_title>
  <acronym>Chime</acronym>
  <official_title>Phase II Single Arm Trial of FOLF(HA)Iri Plus Cetuximab in Irinotecan-naïve Second Line Patients With KRAS Wild Type Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western General Hospital, Australia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alchemia Oncology</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merck Serono International SA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Western General Hospital, Australia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing&#xD;
      chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for&#xD;
      delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of&#xD;
      hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in&#xD;
      optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific&#xD;
      example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced&#xD;
      efficacy in both nonclinical and early clinical studies.&#xD;
&#xD;
      The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm&#xD;
      trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild&#xD;
      type metastatic colorectal cancer. The study objectives are to confirm the safety and&#xD;
      efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic&#xD;
      colorectal cancer patients.&#xD;
&#xD;
      It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent&#xD;
      treatment and follow up; thus the trial will run for approximately 2-3 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">November 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <phase>Phase 2</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>Safety</measure>
    <time_frame>2 years</time_frame>
    <description>To assess FOLF(HA)iri plus cetuximab with respect to:&#xD;
Patient safety, including incidence of severe (Grade 3/4) toxicity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>HA-Irinotecan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HA-Irinotecan</intervention_name>
    <description>HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.</description>
    <arm_group_label>HA-Irinotecan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Tumour is KRAS wild type&#xD;
&#xD;
          -  mCRC with disease progression after first-line chemotherapy (adjuvant chemotherapy is&#xD;
             considered first line chemotherapy if metastatic progression occurs within 6 months of&#xD;
             the end of the adjuvant chemotherapy).&#xD;
&#xD;
          -  Irinotecan naïve&#xD;
&#xD;
          -  Prior use of bevacizumab in the 1st line setting is permitted.&#xD;
&#xD;
          -  ECOG 0 or 1&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
          -  Histological proof of colorectal adenocarcinoma&#xD;
&#xD;
          -  18+ years of age&#xD;
&#xD;
          -  Adequately recovered from and at least 4 weeks after recent major surgery or&#xD;
             chemotherapy&#xD;
&#xD;
          -  At least 4 weeks after treatment with a biologic monotherapy from last dose to&#xD;
             enrolment.&#xD;
&#xD;
          -  Hematology done within 14 days prior to enrolment :&#xD;
&#xD;
               -  Absolute Neutrophil count (ANC) greater than 1.5 x 109/L&#xD;
&#xD;
               -  Platelets greater than 100 x 109/L&#xD;
&#xD;
               -  Hemoglobin greater than or equal to 100g/L&#xD;
&#xD;
          -  Chemistry done within 14 days prior to enrolment:&#xD;
&#xD;
               -  AST greater than or equal to 2.5 X ULN (greater than 5 X ULN if elevation thought&#xD;
                  to be related to hepatic metastatic disease),&#xD;
&#xD;
               -  Alkaline phosphatase greater than 5 x ULN,&#xD;
&#xD;
               -  Serum creatinine greater than 1.5 x ULN,&#xD;
&#xD;
               -  Total bilirubin greater than 34.2 µmol/L,&#xD;
&#xD;
               -  Negative serum or urine pregnancy test if a WOCBP.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  KRAS mutant.&#xD;
&#xD;
          -  Prior irinotecan&#xD;
&#xD;
          -  Prior anti-EGFR&#xD;
&#xD;
          -  History of other malignancies, except adequately treated non-melanoma skin cancer,&#xD;
             curatively treated in-situ cancer of the cervix, or other solid tumours curatively&#xD;
             treated with no evidence of disease for greater than 5 years.&#xD;
&#xD;
          -  Locally advanced or recurrent disease only&#xD;
&#xD;
          -  Unsuitability for irinotecan&#xD;
&#xD;
          -  Abdominal or pelvic radiation therapy (including treatment with SIR-Spheres/Sirtex)&#xD;
             within the last 12 months.&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding.&#xD;
&#xD;
          -  Significant cardiac disease&#xD;
&#xD;
          -  Untreated or symptomatic brain or central nervous system (CNS) metastases&#xD;
&#xD;
          -  Presence of pleural effusion or ascites requiring therapeutic thoracocentesis or&#xD;
             paracentesis.&#xD;
&#xD;
          -  Current partial or complete bowel obstruction.&#xD;
&#xD;
          -  Concomitant active infection.&#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>Peter Gibbs, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Gibbs, MD</last_name>
    <email>Peter.Gibbs@mh.org.au</email>
  </overall_contact>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>1871</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Weng Ng, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southern Medical Day Care Centre</name>
      <address>
        <city>Wollongong</city>
        <state>New South Wales</state>
        <zip>2500</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Philip Clingan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Gibbs, MD</last_name>
      <email>Peter.Gibbs@mh.org.au</email>
    </contact>
    <investigator>
      <last_name>Peter Gibbs, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 27, 2014</last_update_submitted>
  <last_update_submitted_qc>August 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Hospital, Australia</investigator_affiliation>
    <investigator_full_name>Peter Gibbs</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>mCRC</keyword>
  <keyword>colorectal cancer</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>Irinotecan</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/NCT02216487
org study id: ACO-004
nct id: NCT02216487
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
As an approach to improve efficacy and provide clinical benefit to cancer patients undergoing
      chemotherapeutic treatment regimens, Alchemia Oncology has developed a novel means for
      delivering anti-cancer agents to tumours. The drug delivery platform is based on the use of
      hyaluronic acid (HA), a novel excipient, in which, formulation with HA results in
      optimisation of cytotoxic drug uptake and retention within solid tumours. In the specific
      example of HA-Irinotecan, this new formulation of irinotecan has demonstrated enhanced
      efficacy in both nonclinical and early clinical studies.

      The current study is an investigation into the use of HA-Irinotecan in a Phase II single arm
      trial of FOLF(HA)iri plus cetuximab in irinotecan-naïve second line patients with KRAS wild
      type metastatic colorectal cancer. The study objectives are to confirm the safety and
      efficacy of FOLF(HA)iri plus cetuximab as second-line therapy in irinotecan-naïve metastatic
      colorectal cancer patients.

      It is expected that the study recruit approximately 40-50 patients in 1 year with subsequent
      treatment and follow up; thus the trial will run for approximately 2-3 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: 2 years
description: To assess FOLF(HA)iri plus cetuximab with respect to:
Patient safety, including incidence of severe (Grade 3/4) toxicity according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03).
arm group label: HA-Irinotecan
arm group type: Experimental
description: HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan.
intervention type: Drug
intervention name: HA-Irinotecan
description: HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.
arm group label: HA-Irinotecan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Gibbs, MD
role: Principal Investigator
affiliation: Western General Hospital
last name: Peter Gibbs, MD
email: Peter.Gibbs@mh.org.au
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Western Hospital, Australia
investigator full name: Peter Gibbs
investigator title: Associate Professor
mesh term: Colorectal Neoplasms
mesh term: Irinotecan