<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/NCT02999750</url>
  </required_header>
  <id_info>
    <org_study_id>EXACT</org_study_id>
    <nct_id>NCT02999750</nct_id>
  </id_info>
  <brief_title>EXtendedAnalysis for Cancer Treatment</brief_title>
  <official_title>EXACT: EXtendedAnalysis for Cancer Treatment A Prospective Investigator-initiated Translational Study Evaluating Individualized Treatment Regiments Based on Respective Biomarker Analyses for Refractory Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to prospectively validate treatment benefit of an individualized&#xD;
      treatment concept based on molecular profiling (MP) from paraffin-embedded tumor tissue&#xD;
      sections obtained before the start of treatment (real time biopsy).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment concept will be considered to be of clinical benefit for the individual patient&#xD;
      if a progression-free survival (PFS) ratio (PFS on MP-based therapy / best PFS achieved by&#xD;
      prior therapy) will be &gt; 1.0 thus generating a patient cohort with this very property.&#xD;
      Thereby, the null hypothesis (that ≤ 40 % of this patient population would have a PFS ratio&#xD;
      of &gt; 1.0) will be evaluated with each patient being his own control. For tumor types with&#xD;
      high numbers of patients per cohort, the overall response rate (ORR) will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</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>Use of real time biopsy to establish an individual molecular profile by using next generation sequencing</measure>
    <time_frame>2 years</time_frame>
    <description>pathological examination (includes genetic and target expression profiling, and drug sensitivity screening) to rank treatment options and the potential correlation between treatment response and progression free survival</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Malignant Solid Tumor</condition>
  <arm_group>
    <arm_group_label>individual therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>individual therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>individual therapy</intervention_name>
    <description>Patient will be treated with individual therapy.</description>
    <arm_group_label>individual therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Consenting patients of &gt;19 years with advanced cancer fulfilling the criteria of having:&#xD;
&#xD;
          -  an advanced malignancy with metastatic spread refractory to conventional treatment&#xD;
&#xD;
          -  a life expectancy of &gt;4 months,&#xD;
&#xD;
          -  the possibility to access and biopsy tumour material within 4 weeks before onset of&#xD;
             individualized treatment,&#xD;
&#xD;
          -  a malignancy amenable to further treatment options with either cytotoxic drugs,&#xD;
             tyrosine kinase inhibitors, monoclonal antibodies or related molecules with&#xD;
             anti-proliferative potential to cancer cells, as assessed by the ex vivo analysis and&#xD;
             a likelihood of treatment response according to the mathematical model (all outlined&#xD;
             in detail above),&#xD;
&#xD;
          -  agreed to participate by their signature on an informed consent form are eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of further treatment options, as defined by NCCN guidelines which are&#xD;
             available in Austria representing a possible further treatment-related response by&#xD;
             conventional therapies according to generally accepted medical evidence.&#xD;
&#xD;
          -  No fresh and viable tumor material available.&#xD;
&#xD;
          -  Current use of therapeutic warfarin.&#xD;
&#xD;
          -  Unresolved toxicity of National Cancer Institute Common Terminology Criteria for&#xD;
             Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous&#xD;
             anti-cancer therapy, except alopecia.&#xD;
&#xD;
          -  Presence of active gastrointestinal disease or other condition that will interfere&#xD;
             significantly with the absorption of drugs.&#xD;
&#xD;
          -  A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or&#xD;
             Hepatitis C Virus (HCV) infection.&#xD;
&#xD;
          -  A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.&#xD;
&#xD;
          -  History of other malignancy. Subjects who have been disease-free for 5 years or those&#xD;
             with a history of completely resected non-melanoma skin cancer or successfully treated&#xD;
             in situ carcinoma are eligible.&#xD;
&#xD;
          -  Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc),&#xD;
             psychological, familial, sociological, or geographical conditions that do not permit&#xD;
             compliance with the protocol)&#xD;
&#xD;
          -  unwillingness or inability to follow the procedures required in the protocol.&#xD;
&#xD;
          -  pregnant or lactating females.&#xD;
&#xD;
          -  History of alcohol or drug abuse within 6 months prior to screening.&#xD;
&#xD;
          -  No informed consent available.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AKH Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Gerald Prager</investigator_full_name>
    <investigator_title>Univ. Prof. Dr.</investigator_title>
  </responsible_party>
  <!-- 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/NCT02999750
org study id: EXACT
nct id: NCT02999750
lead sponsor: 
has dmc: No
The purpose of this study is to prospectively validate treatment benefit of an individualized
      treatment concept based on molecular profiling (MP) from paraffin-embedded tumor tissue
      sections obtained before the start of treatment (real time biopsy).
The treatment concept will be considered to be of clinical benefit for the individual patient
      if a progression-free survival (PFS) ratio (PFS on MP-based therapy / best PFS achieved by
      prior therapy) will be > 1.0 thus generating a patient cohort with this very property.
      Thereby, the null hypothesis (that ≤ 40 % of this patient population would have a PFS ratio
      of > 1.0) will be evaluated with each patient being his own control. For tumor types with
      high numbers of patients per cohort, the overall response rate (ORR) will be evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Use of real time biopsy to establish an individual molecular profile by using next generation sequencing
time frame: 2 years
description: pathological examination (includes genetic and target expression profiling, and drug sensitivity screening) to rank treatment options and the potential correlation between treatment response and progression free survival
arm group label: individual therapy
arm group type: Other
description: individual therapy
intervention type: Other
intervention name: individual therapy
description: Patient will be treated with individual therapy.
arm group label: individual therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Gerald Prager
investigator title: Univ. Prof. Dr.