<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/NCT02199223</url>
  </required_header>
  <id_info>
    <org_study_id>HCI72561</org_study_id>
    <nct_id>NCT02199223</nct_id>
  </id_info>
  <brief_title>Regorafenib + Panitumumab for Colorectal Cancers</brief_title>
  <official_title>Combination Study of Panitumumab and Regorafenib in Advanced or Metastatic KRAS and NRAS Wild Type Colorectal Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the safety of regorafenib and panitumumab&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Safety of regorafenib + panitumumab</measure>
    <time_frame>Safety of the drug combination will be measured by number and severity of adverse events experienced while patients are on treatment which will be about 2-3 months if not more depending on the response to treatment.</time_frame>
    <description>safety of combination for duration of treatment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>KRAS and NRAS Wild-type Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>panitumumab + regorafenib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>regorafenib + panitumumab</intervention_name>
    <arm_group_label>panitumumab + regorafenib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological diagnosis of un-resectable or metastatic colorectal cancer which is KRAS&#xD;
             and NRAS mutation negative (wild-type). Patients with any known mutation in KRAS or&#xD;
             NRAS codons 12, 13, 59, 61, 117 or 146 will be excluded. Mutations of KRAS and NRAS&#xD;
             codons not listed above are allowed. Biopsy of metastatic lesion is not required.&#xD;
&#xD;
          -  Patients must show signs of progression (by imaging, or tumor marker elevation) after&#xD;
             being treated with a first line or greater treatment for their un-resectable or&#xD;
             metastatic colorectal cancer.&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  ECOG Performance Status 0-1&#xD;
&#xD;
          -  Subjects must be able to understand and be willing to sign the written informed&#xD;
             consent form. A signed informed consent form must be appropriately obtained prior to&#xD;
             the conduct of any trial-specific procedure.&#xD;
&#xD;
          -  Acute toxic effects of all prior treatment have resolved to NCI-CTCAE v4.0 less than&#xD;
             or equal to Grade 1 or baseline prior to beginning treatment. Alopecia (any grade) is&#xD;
             allowed. Peripheral neuropathy less than or equal to Grade 2 is allowed.&#xD;
&#xD;
          -  Adequate bone marrow, renal and liver function as assessed by protocol laboratory&#xD;
             requirements&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum pregnancy test performed&#xD;
             within 7 days prior to the start of study drug. Post-menopausal women (defined as no&#xD;
             menses for at least 1 year) and surgically sterilized women are not required to&#xD;
             undergo a pregnancy test.&#xD;
&#xD;
          -  Subjects (men and women) of childbearing potential must agree to use adequate&#xD;
             contraception beginning at the signing of the ICF until at least 3 months after the&#xD;
             last dose of study drug. Highly effective contraception must be used (e.g. male condom&#xD;
             with spermicidal, diaphragm with spermicidal, intra-uterine device) must be used by&#xD;
             both sexes.&#xD;
&#xD;
          -  Subject must be able to swallow medication.&#xD;
&#xD;
          -  Measurable disease at screening by RECIST 1.1 criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any known mutation in KRAS or NRAS codons 12, 13, 59, 61, 117 or 146.&#xD;
&#xD;
          -  Prior use of regorafenib.&#xD;
&#xD;
          -  Known or suspected grade 3 allergy or hypersensitivity to any of the study drugs,&#xD;
             study drug classes, or excipients of the formulations given during the course of the&#xD;
             trial.&#xD;
&#xD;
          -  Uncontrolled hypertension (systolic pressure greater than140 mm Hg or diastolic&#xD;
             pressure greater than 90 mm Hg [NCI-CTCAE v4.0] on mean of 3 consecutive readings&#xD;
             despite optimal medical management. Hypertension may be corrected by adding or&#xD;
             adjusting anti-hypertensives prior to the initiation of treatment at the discretion of&#xD;
             the practitioner.&#xD;
&#xD;
          -  Active or clinically significant cardiac disease including congestive heart failure,&#xD;
             uncontrolled cardiac arrhythmias, or unstable angina.&#xD;
&#xD;
          -  Evidence or history of congenital or acquired hypocoagulability disorders.&#xD;
&#xD;
          -  Any hemorrhage or bleeding event greater than or equal to NCI CTCAE v.4.0 Grade 3&#xD;
             within 4 weeks prior to start of study medication.&#xD;
&#xD;
          -  Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular&#xD;
             accident (including transient ischemic attacks) deep vein thrombosis or pulmonary&#xD;
             embolism that have initiated within 6 months of start of study treatment. Stable,&#xD;
             persistent events under appropriate management diagnosed greater than 6 months prior&#xD;
             to treatment are allowed at the discretion of the investigator.&#xD;
&#xD;
          -  Subjects who are receiving treatment for a concurrent cancer that is distinct in&#xD;
             primary site or histology from colorectal carcinoma, except any cancer in-situ,&#xD;
             treated basal cell or squamous cell carcinoma, or superficial bladder tumor. Subjects&#xD;
             surviving a cancer that was curatively treated and without evidence of disease more&#xD;
             than 1 year before randomization are allowed. All cancer treatments must be completed&#xD;
             at least 1 year prior to start of study treatment.&#xD;
&#xD;
          -  Patients with severe hepatic impairment (Child-Pugh Class C).&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV) infection or current chronic or&#xD;
             active hepatitis B or C infection requiring treatment with antiviral therapy. Baseline&#xD;
             testing is not required.&#xD;
&#xD;
          -  Patients requiring IV antiviral or IV antibiotic treatment for ongoing infections.&#xD;
&#xD;
          -  Symptomatic metastatic brain or meningeal tumors. Baseline brain imaging is not&#xD;
             required.&#xD;
&#xD;
          -  Presence of a non-healing wound or bone fracture.&#xD;
&#xD;
          -  Patient's with a history of kidney disease or persistent proteinuria must have less&#xD;
             than Grade 3 proteinuria per NCI CTCAE v4.0 at screening. If a patient has a history&#xD;
             of kidney disease or persistent proteinuria, a urine protein test will be performed on&#xD;
             a random urine sample. If the result is normal then no additional testing is required.&#xD;
             If the result is abnormal, a 24 hour urine will be collected to determine if&#xD;
             proteinuria is less than Grade 3.&#xD;
&#xD;
          -  Interstitial lung disease with ongoing signs and symptoms at the time of informed&#xD;
             consent.&#xD;
&#xD;
          -  Any malabsorption condition that in the opinion of the investigator would&#xD;
             significantly impact drug absorption.&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding.&#xD;
&#xD;
          -  Any condition which, in the investigator's opinion, makes the subject unsuitable for&#xD;
             trial participation.&#xD;
&#xD;
          -  Substance abuse, medical, psychological or social conditions that in the opinion of&#xD;
             the investigator may interfere with the subject's participation in the study or&#xD;
             evaluation of the study results.&#xD;
&#xD;
          -  Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery,&#xD;
             immunotherapy, biologic therapy, or tumor embolization) within 3 weeks of starting&#xD;
             study treatment.&#xD;
&#xD;
          -  Concurrent use of another investigational drug or device during, or within 3 weeks of&#xD;
             starting study treatment.&#xD;
&#xD;
          -  Major surgical procedure, open biopsy, or significant traumatic injury within 3 weeks&#xD;
             before start of study medication.&#xD;
&#xD;
          -  Concurrent use of strong CYP3a4 inducers (e.g. rifampin, phenytoin, carbamazepine,&#xD;
             phenobarbital, and St. John's Wort)&#xD;
&#xD;
          -  Concurrent use with strong inhibitors of CYP3A4 (e.g. clarithromycin, grapefruit&#xD;
             juice, itraconazole, ketoconazole, nefazadone, posaconazole, telithromycin, and&#xD;
             voriconazole)&#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>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>September 21, 2016</last_update_submitted>
  <last_update_submitted_qc>September 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2016</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>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Panitumumab</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/NCT02199223
org study id: HCI72561
nct id: NCT02199223
lead sponsor: 
has dmc: Yes
Evaluate the safety of regorafenib and panitumumab
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of regorafenib + panitumumab
time frame: Safety of the drug combination will be measured by number and severity of adverse events experienced while patients are on treatment which will be about 2-3 months if not more depending on the response to treatment.
description: safety of combination for duration of treatment
arm group label: panitumumab + regorafenib
arm group type: Experimental
intervention type: Drug
intervention name: regorafenib + panitumumab
arm group label: panitumumab + regorafenib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Panitumumab