<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/NCT03306394</url>
  </required_header>
  <id_info>
    <org_study_id>CL3-95005-004</org_study_id>
    <secondary_id>2016-002311-18</secondary_id>
    <nct_id>NCT03306394</nct_id>
  </id_info>
  <brief_title>A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic).</brief_title>
  <acronym>PRECONNECT</acronym>
  <official_title>An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherches Internationales Servier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ADIR, a Servier Group company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Servier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect additional safety and efficacy data during treatment&#xD;
      with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer&#xD;
      (mCRC).&#xD;
&#xD;
      Eligible patients may receive an early access to trifluridine / tipiracil through this&#xD;
      clinical study until progression of disease, unacceptable toxicity, investigator decision,&#xD;
      patient refusal or until market authorization or reimbursement has been granted by the&#xD;
      relevant Authority of the country where that patient is treated or until trifluridine /&#xD;
      tipiracil is available by a doctor's prescription or can be accessed from another source or&#xD;
      Sponsor decision.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 18, 2016</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <phase>Phase 3</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>Incidence of Adverse Events [safety and tolerability]</measure>
    <time_frame>Through 28 days following last administration of study medication</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Abnormalities in laboratory assessment</measure>
    <time_frame>Through study completion, an average of 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Abnormalities in performance status (ECOG)</measure>
    <time_frame>Through study completion, an average of 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Abnormalities in vital signs</measure>
    <time_frame>Through study completion, an average of 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>Through study completion, an average of 12 weeks</time_frame>
    <description>time from the date of first study drug intake until the date of the investigator-assessed disease progression or death due to any cause whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using the questionnaire EQ-5D</measure>
    <time_frame>Through study completion, an average of 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using the questionnaire EORTC QLQ-C30</measure>
    <time_frame>Through study completion, an average of 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">907</enrollment>
  <condition>Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>S95005</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride, taken orally twice a day at the dose of 35 mg/m²/dose. The treatment is given until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trifluridine/Tipiracil hydrochloride (S95005)</intervention_name>
    <arm_group_label>S95005</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female participant aged ≥18 years old.&#xD;
&#xD;
          -  Has definitive histologically confirmed adenocarcinoma of the colon or rectum.&#xD;
&#xD;
          -  Has metastatic lesion(s).&#xD;
&#xD;
          -  Has received at least 2 prior regimens of standard chemotherapies (including&#xD;
             fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at&#xD;
             least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC&#xD;
             and is refractory or intolerant to those chemotherapies or is not candidate for those&#xD;
             chemotherapies.&#xD;
&#xD;
          -  Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the&#xD;
             screening period.&#xD;
&#xD;
          -  Is able to take medications orally (i.e., no feeding tube).&#xD;
&#xD;
          -  Has adequate organ function.&#xD;
&#xD;
          -  Women of childbearing potential must have been tested negative in a serum pregnancy&#xD;
             test within 7 days prior to first day of test drug administration. Female participants&#xD;
             of childbearing potential and male participants with partners of childbearing&#xD;
             potential must agree to use a highly effective method of birth control during the&#xD;
             study and for 6 months after the discontinuation of study medication. Women and female&#xD;
             partners using hormonal contraceptive must also use a barrier method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, breastfeeding or possibility of becoming pregnant during the study.&#xD;
&#xD;
          -  Eligible for enrolment into another available ongoing clinical study of trifluridine /&#xD;
             tipiracil.&#xD;
&#xD;
          -  Has previously received trifluridine / tipiracil or hypersensitivity to the active&#xD;
             substances or to any of the excipients of trifluridine / tipiracil.&#xD;
&#xD;
          -  Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or&#xD;
             glucose-galactose malabsorption.&#xD;
&#xD;
          -  Has certain serious illness or medical condition(s) described in the protocol.&#xD;
&#xD;
          -  Has had certain other recent treatment e.g. major surgery, anticancer therapy,&#xD;
             radiation therapy, participation in another interventional study, within the specified&#xD;
             time frames prior to first day of study drug administration.&#xD;
&#xD;
          -  Has unresolved toxicity of greater than or equal to Common Terminology Criteria for&#xD;
             Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia,&#xD;
             alopecia, skin pigmentation, and platinum-induced neurotoxicity).&#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>Chris O'Brien Lifehouse Oncology</name>
      <address>
        <city>Camperdown</city>
        <zip>NSW 2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital The Kinghorn Cancer Centre</name>
      <address>
        <city>Darlinghurst</city>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital (Melbourne) Cancer Centre</name>
      <address>
        <city>Fitzroy</city>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Canberra Hospital Cancer,Ambulatory &amp; Community Health Service (CACHS) Bldg 19</name>
      <address>
        <city>Garran</city>
        <zip>2605</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane &amp; Women's Hospital Clinical Research Unit</name>
      <address>
        <city>Herston</city>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabrini Hospital Cabrini Haematology and Oncology Centre</name>
      <address>
        <city>Malvern</city>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perth Oncology - Mount Hospital</name>
      <address>
        <city>Perth</city>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Queen Elizabeth Hospital Haematology and Oncology Unit</name>
      <address>
        <city>Woodville</city>
        <zip>SA 5011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Universitaire Erasme Gastro-Entérologie</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires St. Luc Oncologie médicale</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen Oncologie</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.Z. Gent Digestieve Oncologie</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven Campus Gasthuisberg Digestieve Oncologie</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Mãe de Deus Centro Intergrado de Pesquisa</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90470-340</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinicas Oncológicas Integradas (COI)</name>
      <address>
        <city>Rio De Janeiro</city>
        <zip>22793-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMO Assistencia Multidisciplinar em Oncologia GEM Assistencia Medica Especializada</name>
      <address>
        <city>Salvador</city>
        <zip>41950-610</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Cancer do Estado de Sao Paulo - ICESP Núcleo de Pesquisa</name>
      <address>
        <city>São Paulo</city>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital A C Camargo Unidade de Pesquisa Clínica</name>
      <address>
        <city>São Paulo</city>
        <zip>01509-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica</name>
      <address>
        <city>São Paulo</city>
        <zip>03102-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complex oncology center - Plovdiv</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Medical Academy - MHAT Oncology clinic</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized hospital for active treatment in oncology</name>
      <address>
        <city>Sofia</city>
        <zip>1756</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SHAT of oncology diseases</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju</name>
      <address>
        <city>Rijeka</city>
        <zip>51000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Zagreb Klinika za onkologiju</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Privé Les Bonnettes Pharmacie centrale</name>
      <address>
        <city>Arras</city>
        <zip>62000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Sainte Catherine Institut Sainte Catherine</name>
      <address>
        <city>Avignon</city>
        <zip>84918</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de lutte contre le cancer Francois Baclesse UCP Digestif</name>
      <address>
        <city>Caen</city>
        <zip>14076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive</name>
      <address>
        <city>Chambray Les Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D</name>
      <address>
        <city>Grenoble Cedex 9</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD - Les Oudairies service d'hepato-gastroenterologie</name>
      <address>
        <city>La Roche Sur Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franco-British Institue Department of Medical Oncology</name>
      <address>
        <city>Levallois Perret</city>
        <zip>92300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRLCC Léon Bérard Service d'Oncologie</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de la Timone Hépato-Gastro-Entérologie</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale</name>
      <address>
        <city>Montbeliard</city>
        <zip>25209</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRLCC Val d'Aurelle Oncologie Médicale</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne Dpt d'Oncologie Médicale</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Antoine Service d'Oncologie Médicale</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie</name>
      <address>
        <city>Paris</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Haut-Lévèque Hépato-gastroentérologie et oncologie digestive</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers Pole Régional de Cancérologie</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Eugène Marquis Service d'Oncologie Médicale</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord Pôle Digestif Urologie-Andrologie</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse Rangueil Oncologie médicale digestive</name>
      <address>
        <city>TOULOUSE cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours Hospital</name>
      <address>
        <city>Cork</city>
        <zip>90</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Adelaide and Meath Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>24</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ist.Tumori &quot;Giovanni Paolo II&quot; IRCCS Osp.Oncologico di Bari U.O.C. di Oncologia Medica</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Poliambulanza Istituto Ospedaliero Clinical Oncology</name>
      <address>
        <city>Brescia</city>
        <zip>25124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica</name>
      <address>
        <city>Catania</city>
        <zip>95122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology</name>
      <address>
        <city>Meldola</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Seconda Università degli Studi di Napoli U.O.C. di Oncologia Medica e di Ematologia</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera &quot;Civico-Di Cristina&quot; - Ospedale Civico Oncologia Medica</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Civile Santo Spirito Struttura Complessa di Oncologia Medica</name>
      <address>
        <city>Pescara</city>
        <zip>64124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcispedale Santa Maria Nuova Unità di Oncologia</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale INFERMI Reparto di Oncologia</name>
      <address>
        <city>Rimini</city>
        <zip>47923</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Campus Biomedico UOC di Oncologia Medica</name>
      <address>
        <city>Roma</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Agostino Gemelli U.O.C. di Oncologia Medica</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia</name>
      <address>
        <city>Rozzano (mi)</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hemato-Oncologico de Panama</name>
      <address>
        <city>Panamá</city>
        <zip>0832_00752</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej</name>
      <address>
        <city>Bialystok</city>
        <zip>15-027</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej</name>
      <address>
        <city>Opole</city>
        <zip>46-020</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii</name>
      <address>
        <city>Poznan</city>
        <zip>61-866</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magodent Sp. z o.o.</name>
      <address>
        <city>Warszawa</city>
        <zip>04-125</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Garcia de Orta Serviço de Oncologia Médica</name>
      <address>
        <city>Almada</city>
        <zip>2805-267</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Português de Oncologia de Coimbra Serviço de Oncologia Médica</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Português de Oncologia do Porto Serviço de Oncologia Médica</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de São João E.P.E. Serviço de Oncologia</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic &quot;Fundeni&quot; Departament Oncologie Medicala - Gastroenterologie</name>
      <address>
        <city>Bucuresti</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Oncologic &quot;Prof. Dr. I. Chiricuta&quot; Cluj Napoca Oncologie Medicala</name>
      <address>
        <city>Cluj-napoca</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala</name>
      <address>
        <city>Iasi</city>
        <zip>700483</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA</name>
      <address>
        <city>Bratislava</city>
        <zip>81250</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie</name>
      <address>
        <city>Kosice</city>
        <zip>04191</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkoloski Institut Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gazi University Faculty of Medicine Medical Oncology Department</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Faculty of Medicine</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uludag University Faculty of Medicine</name>
      <address>
        <city>Bursa</city>
        <zip>16059</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trakya University Faculty of Medicine</name>
      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marmara University Pendik Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege University Faculty of Medicine Medical Oncology Department</name>
      <address>
        <city>Izmir</city>
        <zip>36040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erciyes University Mehmet Kemal Dedeman Hematology Oncology</name>
      <address>
        <city>Kayseri</city>
        <zip>38039</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kharkiv Regional Oncology Center</name>
      <address>
        <city>Kharkiv</city>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Clinical Oncological Centre Day care facility</name>
      <address>
        <city>Kiev</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology &quot;LISOD</name>
      <address>
        <city>Kyiv</city>
        <zip>08720</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Treatment-diagnostic Centre PJSC &quot;House of medicine&quot;</name>
      <address>
        <city>Odesa</city>
        <zip>65006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Croatia</country>
    <country>France</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Panama</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Slovakia</country>
    <country>Slovenia</country>
    <country>Turkey</country>
    <country>Ukraine</country>
  </location_countries>
  <removed_countries>
    <country>Switzerland</country>
  </removed_countries>
  <link>
    <url>https://clinicaltrials.servier.com/wp-content/uploads/CL3-095005-004-laysummary-2021.09.22.pdf.pdf</url>
    <description>Lay Summary</description>
  </link>
  <link>
    <url>https://clinicaltrials.servier.com/wp-content/uploads/CL3-095005-004-anonymisedsynopsis-2021.06.21.pdf.pdf</url>
    <description>Results Summary</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>November 9, 2021</last_update_submitted>
  <last_update_submitted_qc>November 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metastatic</keyword>
  <keyword>colorectal</keyword>
  <keyword>cancer</keyword>
  <keyword>trifluridine/tipiracil</keyword>
  <keyword>early access</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>Trifluridine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.&#xD;
Access can be requested for all interventional clinical studies:&#xD;
used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).&#xD;
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.&#xD;
In addition, access can be requested for all interventional clinical studies in patients:&#xD;
sponsored by Servier&#xD;
with a first patient enrolled as of 1 January 2004 onwards&#xD;
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After Marketing Authorisation in EEA or US if the study is used for the approval.</ipd_time_frame>
    <ipd_access_criteria>Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.</ipd_access_criteria>
    <ipd_url>http://clinicaltrials.servier.com</ipd_url>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
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      <doc_type>Study Protocol</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
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      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
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      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
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    <study_doc>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://clinicaltrials.servier.com/</doc_url>
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      <doc_url>https://clinicaltrials.servier.com/</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03306394
org study id: CL3-95005-004
secondary id: 2016-002311-18
nct id: NCT03306394
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated device: No
is us export: Yes
The purpose of this study is to collect additional safety and efficacy data during treatment
      with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer
      (mCRC).

      Eligible patients may receive an early access to trifluridine / tipiracil through this
      clinical study until progression of disease, unacceptable toxicity, investigator decision,
      patient refusal or until market authorization or reimbursement has been granted by the
      relevant Authority of the country where that patient is treated or until trifluridine /
      tipiracil is available by a doctor's prescription or can be accessed from another source or
      Sponsor decision.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Adverse Events [safety and tolerability]
time frame: Through 28 days following last administration of study medication
measure: Abnormalities in laboratory assessment
time frame: Through study completion, an average of 12 weeks
measure: Abnormalities in performance status (ECOG)
time frame: Through study completion, an average of 12 weeks
measure: Abnormalities in vital signs
time frame: Through study completion, an average of 12 weeks
measure: Progression free survival (PFS)
time frame: Through study completion, an average of 12 weeks
description: time from the date of first study drug intake until the date of the investigator-assessed disease progression or death due to any cause whichever occurs first.
measure: Quality of life using the questionnaire EQ-5D
time frame: Through study completion, an average of 12 weeks
measure: Quality of life using the questionnaire EORTC QLQ-C30
time frame: Through study completion, an average of 12 weeks
arm group label: S95005
arm group type: Experimental
description: Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride, taken orally twice a day at the dose of 35 mg/m²/dose. The treatment is given until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
intervention type: Drug
intervention name: Trifluridine/Tipiracil hydrochloride (S95005)
arm group label: S95005
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: Belgium
country: Brazil
country: Bulgaria
country: Croatia
country: France
country: Ireland
country: Italy
country: Panama
country: Poland
country: Portugal
country: Romania
country: Slovakia
country: Slovenia
country: Turkey
country: Ukraine
country: Switzerland
url: https://clinicaltrials.servier.com/wp-content/uploads/CL3-095005-004-laysummary-2021.09.22.pdf.pdf
description: Lay Summary
url: https://clinicaltrials.servier.com/wp-content/uploads/CL3-095005-004-anonymisedsynopsis-2021.06.21.pdf.pdf
description: Results Summary
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Trifluridine
sharing ipd: Yes
ipd description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.
In addition, access can be requested for all interventional clinical studies in patients:
sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
ipd access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
ipd url: http://clinicaltrials.servier.com
study doc: 
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