<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/NCT01666431</url>
  </required_header>
  <id_info>
    <org_study_id>SZ10ON03</org_study_id>
    <nct_id>NCT01666431</nct_id>
  </id_info>
  <brief_title>Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <brief_summary>
    <textblock>
      Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high&#xD;
      frequency of EGF-R expression. EGFR is an important regulator of tumour progression and&#xD;
      proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or&#xD;
      HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition&#xD;
      of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the&#xD;
      investigators hypothesise that EGFR signalling pathway and its interactions play an important&#xD;
      role in the SCC pathogenesis and represent a good therapeutic target from these tumours.&#xD;
&#xD;
      Primary Objectives:&#xD;
&#xD;
      To evaluate the tumour response macroscopically in patients with primary cutaneous SCC&#xD;
      lesions and in concomitant SCC in situ (AK).&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in&#xD;
           patients with SCC as measured by time to first AE or SAE within the study period.&#xD;
&#xD;
        -  To investigate the molecular tumour response of squamous cell carcinoma lesions in&#xD;
           patients under lapatinib treatment using a set of variables.&#xD;
&#xD;
        -  Trial with medicinal product&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>Macroscopic evaluation of tumour response</measure>
    <time_frame>84 days</time_frame>
    <description>The primary efficacy objective is to evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK) by documenting changes in quantity and two-dimensional measurements (mm).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of tolerability</measure>
    <time_frame>84 days</time_frame>
    <description>Evaluation of tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Molecular evaluation of tumour response</measure>
    <time_frame>84 days</time_frame>
    <description>Investigation of molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Squamous Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Lapatinib</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lapatinib</intervention_name>
    <arm_group_label>Lapatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Diagnosis of histologically confirmed cutaneous SCC stage Tis-T2N0 for which surgical&#xD;
             treatment is considered suitable.&#xD;
&#xD;
          -  In case of SCC, patients must present with a minimum of two co-existing AK lesions. In&#xD;
             case of Keratoacanthoma, one lesion of sufficient size (=1cm) is acceptable.&#xD;
&#xD;
          -  All included patients must have both FFPE and frozen material available.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
          -  Adequate organ system function&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Subjects who have current active hepatic or biliary disease&#xD;
&#xD;
          -  Other non-controlled malignancy&#xD;
&#xD;
          -  Clinically significant gastrointestinal abnormalities that may increase the risk for&#xD;
             gastrointestinal bleeding.&#xD;
&#xD;
          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess&#xD;
             within 28 days of study treatment.&#xD;
&#xD;
          -  Presence of uncontrolled infection&#xD;
&#xD;
          -  History of any one or more of the following cardiovascular conditions within the past&#xD;
             6 months:Cardiac angioplasty or stenting;Myocardial infarction;Unstable&#xD;
             angina;Coronary artery bypass graft surgery;Symptomatic peripheral vascular disease;&#xD;
             Class III or IV congestive heart failure, as defined by the New York Heart Association&#xD;
             (NYHA)&#xD;
&#xD;
          -  Poorly controlled hypertension&#xD;
&#xD;
          -  History of cerebrovascular accident including transient ischemic attack (TIA),&#xD;
             pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.&#xD;
&#xD;
          -  Prior exposure to the study drug lapatinib&#xD;
&#xD;
          -  Prior major surgery or trauma within 28 days prior to first dose of study drug and/or&#xD;
             presence of any non-healing wound, fracture, or ulcer&#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>Reinhard Dummer, Professor MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Division of Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Division of Dermatology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</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>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lapatinib</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/NCT01666431
org study id: SZ10ON03
nct id: NCT01666431
lead sponsor: 
Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high
      frequency of EGF-R expression. EGFR is an important regulator of tumour progression and
      proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or
      HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition
      of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the
      investigators hypothesise that EGFR signalling pathway and its interactions play an important
      role in the SCC pathogenesis and represent a good therapeutic target from these tumours.

      Primary Objectives:

      To evaluate the tumour response macroscopically in patients with primary cutaneous SCC
      lesions and in concomitant SCC in situ (AK).

      Secondary Objectives:

        -  To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in
           patients with SCC as measured by time to first AE or SAE within the study period.

        -  To investigate the molecular tumour response of squamous cell carcinoma lesions in
           patients under lapatinib treatment using a set of variables.

        -  Trial with medicinal product
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Macroscopic evaluation of tumour response
time frame: 84 days
description: The primary efficacy objective is to evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK) by documenting changes in quantity and two-dimensional measurements (mm).
measure: Evaluation of tolerability
time frame: 84 days
description: Evaluation of tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period
measure: Molecular evaluation of tumour response
time frame: 84 days
description: Investigation of molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables
arm group label: Lapatinib
arm group type: Other
intervention type: Drug
intervention name: Lapatinib
arm group label: Lapatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Reinhard Dummer, Professor MD
role: Principal Investigator
affiliation: University Hospital Zurich, Division of Dermatology
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Lapatinib