<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/NCT02184416</url>
  </required_header>
  <id_info>
    <org_study_id>A4061078</org_study_id>
    <secondary_id>ADONIS</secondary_id>
    <nct_id>NCT02184416</nct_id>
  </id_info>
  <brief_title>Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting</brief_title>
  <acronym>ADONIS</acronym>
  <official_title>AXITINIB IN ADVANCED / METASTATIC RENAL CELL CARCINOMA - A NON-INTERVENTIONAL STUDY OF REAL WORLD TREATMENT OUTCOMES IN PATIENTS RECEIVING 2ND LINE AXITINIB AFTER 1ST LINE SUNITINIB (ADONIS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an international, multi-centre, prospective (partly retrospective), observational&#xD;
      study to evaluate treatment patterns and clinical outcomes in patients with advanced or&#xD;
      metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line&#xD;
      post sunitinib. The study is designed to enroll approximately 750 patients over the course of&#xD;
      an enrollment period of approximately 36 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in&#xD;
      2nd line post Sutent treatment. The possible sequences of treatment under investigation will&#xD;
      be:&#xD;
&#xD;
        -  Sutent (prospective) - Inlyta&#xD;
&#xD;
        -  Sutent (retrospective) - Inlyta&#xD;
&#xD;
        -  Sutent - not further active treatment (supportive care)&#xD;
&#xD;
        -  Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib),&#xD;
           Afinitor (everolimus), Torisel (temsirolimus), other)) The study will enroll&#xD;
           approximately 750 adv/mRCC patients at the 1st and 2nd line treatment level. Patients&#xD;
           will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd&#xD;
           line post Sutent treatment. Therefore for some patients there will be a retrospective&#xD;
           Sutent data collection. The primary endpoints of this study in patients with adv/mRCC&#xD;
           are PFS and TTF for patients receiving Inlyta in 2nd line, and the combined PFS and TTF&#xD;
           for patients receiving the Sutent-Inlyta sequence. In this non-interventional real life&#xD;
           study, the objective is only descriptive and the sample size will rely on the precision&#xD;
           of the estimate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2014</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>60 months</time_frame>
    <description>PFS for patients with adv/mRCC receiving Inlyta in 2nd line post Sutent is defined as the time from when the patient receives the first dose of Inlyta to the time of progression or death due to any cause, whichever occurs first</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>60 months</time_frame>
    <description>Combined PFS for patients with adv/mRCC receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line, until progression or death due to any cause with Inlyta in 2nd line, whichever occurs first during the Sutent-Inlyta sequence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Treatment Failure (TTF)</measure>
    <time_frame>60 months</time_frame>
    <description>TTF for Inlyta 2nd line is defined as from when the patient receives the first dose of Inlyta to the time of Inlyta discontinuation (date completed by the physician).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Treatment Failure (TTF)</measure>
    <time_frame>60 months</time_frame>
    <description>TTF for the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>60 months</time_frame>
    <description>ORR for adv/mRCC patients receiving Inlyta in 2nd line post Sutent defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST criteria v1.1, relative to all patients who have baseline measurable disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>60 months</time_frame>
    <description>OS for adv/mRCC patients receiving Sutent in first line followed by Inlyta in 2nd line as measured from the date of first Sutent dose to the date of death of any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to strategy failure (TSF)</measure>
    <time_frame>60 months</time_frame>
    <description>TSF for patients receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician) without the time between discontinuation of Sutent and start of Inlyta.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosing</measure>
    <time_frame>60 months</time_frame>
    <description>Description of real life usage of flexible dosing across Europe with description of treatment schedules (dosing change, dosing schedule, average dose received during the period treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of titrated patients</measure>
    <time_frame>60 months</time_frame>
    <description>A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>60 months</time_frame>
    <description>PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>60 months</time_frame>
    <description>Efficacy parameters (PFS, OS) for the combined 1st line Sutent - 2nd line sequences according to the second line post Sutent (other than Sutent-Inlyta)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>60 months</time_frame>
    <description>Safety description with AE listing in patients receiving Inlyta</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL</measure>
    <time_frame>60 months</time_frame>
    <description>QoL using the Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19) questionnaire and the Mental Health (MH) and Role-Emotional (RE) domains of the SF-36 questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">573</enrollment>
  <condition>Metastatic Renal Cell Carcinoma (mRCC)</condition>
  <arm_group>
    <arm_group_label>Observational Arm</arm_group_label>
    <description>Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. The possible sequences of treatment under investigation will be:&#xD;
Sutent (prospective) - Inlyta&#xD;
Sutent (retrospective) - Inlyta&#xD;
Sutent - not further active treatment (supportive care)&#xD;
Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus), other))</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational</intervention_name>
    <description>The study is non interventional. All drugs will be prescribed</description>
    <arm_group_label>Observational Arm</arm_group_label>
    <other_name>Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will enroll adv/mRCC patients when they start a treatment with Sutent in 1st line&#xD;
        or Inlyta in 2nd line post Sutent treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient 18 years of age and over&#xD;
&#xD;
          -  Histologically confirmed diagnosis of advanced/metastatic renal carcinoma (clear cell&#xD;
             RCC as well as non-clear cell RCC) with measurable disease according to RECIST 1.1&#xD;
&#xD;
          -  Patients being treated with Sutent in 1st line according to the European therapeutic&#xD;
             indication and/or being treated with Inlyta in 2nd line according to the European&#xD;
             approved therapeutic indication (except post cytokines)&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the patient (or a legally acceptable representative) has been informed of all&#xD;
             pertinent aspects of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients being treated with cytokines or any other treatment outside of Sutent in 1st&#xD;
             line&#xD;
&#xD;
          -  Patients receiving anti -tumor treatment beyond a second line&#xD;
&#xD;
          -  Patients already under Sutent, already under Inlyta: enrolment must occur at the&#xD;
             beginning of each line of treatment (before or at the first follow up visit at the&#xD;
             latest)&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Landeskrankenhaus Bregenz</name>
      <address>
        <city>Bregenz</city>
        <zip>A-6900</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKh Linz</name>
      <address>
        <city>Linz</city>
        <zip>4021</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie</name>
      <address>
        <city>Linz</city>
        <zip>A-4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Oberwart</name>
      <address>
        <city>Oberwart</city>
        <zip>7400</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitasklinik für Urologie und Andrologie</name>
      <address>
        <city>Salzburg</city>
        <zip>A-5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH - Universitaetsklinik fuer Innere Medizin I</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH-Universitat Klinik fur Innere Medizin I</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sozialmedizinisches Zentrum Ost</name>
      <address>
        <city>Wien</city>
        <zip>1220</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASZ Aalst - Campus Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imeldaziekenhuis</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique St Pierre - Oncologie</name>
      <address>
        <city>Ottignies</city>
        <zip>1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne, Service d'Oncologie</name>
      <address>
        <city>Nice Cedex 2</city>
        <state>Alpes-maritimes</state>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cl du Docteur Calabet / Cromg</name>
      <address>
        <city>Agen</city>
        <zip>47000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers - Hôpital Hôtel Dieu</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier d'Auxerre</name>
      <address>
        <city>Auxerre Cedex</city>
        <zip>89011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Sainte Catherine, Department Oncologie, Medecine Interene</name>
      <address>
        <city>Avignon cedex 2</city>
        <zip>84082</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre d'Oncologie et de Radiotherapie du pays Basque</name>
      <address>
        <city>Bayonne</city>
        <zip>64100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-André</name>
      <address>
        <city>Bordeaux Cedex</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux Cedex</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Bordeaux Tivoli Ducos</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat</name>
      <address>
        <city>Bourg En Bresse Cedex</city>
        <zip>1000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Catalan Urologie Andrologie</name>
      <address>
        <city>Cabestany</city>
        <zip>66330</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H.G. Antoine Gayraud, Medecine Interne</name>
      <address>
        <city>Carcassonne CEDEX 9</city>
        <zip>11890</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Rene Dubos</name>
      <address>
        <city>CERGY Pontoise</city>
        <zip>95303</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Prive Sainte Marie</name>
      <address>
        <city>Chalon sur Saone</city>
        <zip>71100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Gabriel Montpied</name>
      <address>
        <city>Clermont Ferrand Cedex 1</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pole Sante Republique</name>
      <address>
        <city>Clermont Ferrand Cedex 2</city>
        <zip>63050</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont-Ferrand Cedex 1</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre d'Oncologie du Parc</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Clement Drevon</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Sainte Marguerite</name>
      <address>
        <city>Hyères</city>
        <zip>83400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital prive La Louviere</name>
      <address>
        <city>Lille</city>
        <zip>59042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Dupuytren - Oncologie Medicale</name>
      <address>
        <city>Limoges Cedex</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Longjumeau</name>
      <address>
        <city>Longjumeau</city>
        <zip>91160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de la Sauvegarde</name>
      <address>
        <city>Lyon Cedex 09</city>
        <zip>69337</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Nord</name>
      <address>
        <city>Marseille Cedex 20</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Prive Clairval</name>
      <address>
        <city>Marseille Cedex</city>
        <zip>13274</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Timone Adultes</name>
      <address>
        <city>Marseille Cedex</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Clinique Claude-Bernard</name>
      <address>
        <city>Metz Cedex</city>
        <zip>57072</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Belle-Isle</name>
      <address>
        <city>Metz</city>
        <zip>57045</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Intercommunal le Raincy Montfermeil</name>
      <address>
        <city>Montfermeil</city>
        <zip>93370</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Clémentville - Oncologie</name>
      <address>
        <city>Montpellier</city>
        <zip>34070</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre d'Oncologie de Gentilly</name>
      <address>
        <city>Nancy</city>
        <zip>54100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre d'Oncology de Gentilly</name>
      <address>
        <city>Nancy</city>
        <zip>54100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Universitaire Carémeau</name>
      <address>
        <city>Nimes cedex 9</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Pau</name>
      <address>
        <city>Pau</city>
        <zip>64000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique de Francheville</name>
      <address>
        <city>Perigueux</city>
        <zip>24000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud - Service d oncologie medicale</name>
      <address>
        <city>Pierre Benite cedex</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Annecy Genevois</name>
      <address>
        <city>Pringy Cedex</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR Annecy</name>
      <address>
        <city>Pringy Cedex</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jean Godinot</name>
      <address>
        <city>Reims</city>
        <zip>51056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Prive Saint Gregoire</name>
      <address>
        <city>Saint Gregoire Cedex</city>
        <zip>35768</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHP Saint Gregoire</name>
      <address>
        <city>Saint Gregoire</city>
        <zip>35760</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitaier Sud Reunion</name>
      <address>
        <city>Saint Pierre</city>
        <zip>97410</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pôle Hospitalier Mutualiste</name>
      <address>
        <city>Saint-Nazaire</city>
        <zip>44600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cl Armoricaine Radiologie / Radiotherapie</name>
      <address>
        <city>St Brieuc</city>
        <zip>22015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Rene Gauducheau - Service Oncologie Medicale</name>
      <address>
        <city>St Herblain Cedex</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Sud Reunion</name>
      <address>
        <city>St PIERRE Cedex</city>
        <zip>97449</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Radiothérapie,</name>
      <address>
        <city>Strasbourg</city>
        <zip>67010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de Hautepierre-Service Oncologie at Hematologie</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital FOCH</name>
      <address>
        <city>Suresnes Cedex</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Georges Pianta</name>
      <address>
        <city>Thonon les bains</city>
        <zip>74203</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Sainte Musse</name>
      <address>
        <city>Toulon</city>
        <zip>83000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier du Marechal Juin</name>
      <address>
        <city>Valence</city>
        <zip>26000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique les Dentellieres</name>
      <address>
        <city>Valenciennes</city>
        <zip>59300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Jean BERNARD - Tours - 7eme etage</name>
      <address>
        <city>Valenciennes</city>
        <zip>59300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Alexis Vautrin</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Chest Diseases of Athens &quot;Sotiria&quot;</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCC Oncologia Medica</name>
      <address>
        <city>Candiolo (TO)</city>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori</name>
      <address>
        <city>Meldola (FC)</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori, Oncologia Medica B</name>
      <address>
        <city>Milan</city>
        <zip>20100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Divisione di Oncologia, AORN Antonio Cardarelli</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viecuri Medical Centre</name>
      <address>
        <city>BL Venlo</city>
        <zip>5912</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consorcio Hospitalario Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Principe de Asturias</name>
      <address>
        <city>Alcala de Henares</city>
        <zip>28805</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Yague</name>
      <address>
        <city>Burgos</city>
        <zip>09071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta</name>
      <address>
        <city>Gerona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Leon</name>
      <address>
        <city>Leon</city>
        <zip>24071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infanta Leonor</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servicio de Oncologia Medica</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Morales Meseguer</name>
      <address>
        <city>Murcia</city>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias</name>
      <address>
        <city>Santa Cruz de Tenerife</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de La Salud</name>
      <address>
        <city>Toledo</city>
        <zip>45004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salud Hospital Universitario Dr. Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Sanitario Hospital Universitario y Politecnico La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Médico</name>
      <address>
        <city>Vigo</city>
        <zip>36211</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica</name>
      <address>
        <city>Vigo</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultant Oncologist</name>
      <address>
        <city>Cheltenham</city>
        <state>Gloustershire</state>
        <zip>GL53 7AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kent &amp; Canterbury Hospital</name>
      <address>
        <city>Canterbury</city>
        <state>Kent</state>
        <zip>CT1</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Cancer Medicine</name>
      <address>
        <city>Dundee</city>
        <state>Tayside</state>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospital Bath NHS</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Academic Oncology</name>
      <address>
        <city>Cottingham</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital, Royal Marsden NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 7JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Hospital NHS Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061078&amp;StudyName=Study%20Of%20The%20Impact%20Of%20Inlyta%20In%202nd%20Line%20On%20The%20Treatment%20Outcomes%20Of%20mRCC%20Patients%20Treated%20With%20Sutent%20In%201st%20Line%20In%20The%20Re</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inlyta</keyword>
  <keyword>axitinib</keyword>
  <keyword>Sutent</keyword>
  <keyword>sunitinib</keyword>
  <keyword>renal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</mesh_term>
    <mesh_term>Temsirolimus</mesh_term>
    <mesh_term>Sorafenib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02184416/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 10, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02184416/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02184416
org study id: A4061078
secondary id: ADONIS
nct id: NCT02184416
lead sponsor: 
has dmc: No
This is an international, multi-centre, prospective (partly retrospective), observational
      study to evaluate treatment patterns and clinical outcomes in patients with advanced or
      metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line
      post sunitinib. The study is designed to enroll approximately 750 patients over the course of
      an enrollment period of approximately 36 months.
Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in
      2nd line post Sutent treatment. The possible sequences of treatment under investigation will
      be:

        -  Sutent (prospective) - Inlyta

        -  Sutent (retrospective) - Inlyta

        -  Sutent - not further active treatment (supportive care)

        -  Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib),
           Afinitor (everolimus), Torisel (temsirolimus), other)) The study will enroll
           approximately 750 adv/mRCC patients at the 1st and 2nd line treatment level. Patients
           will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd
           line post Sutent treatment. Therefore for some patients there will be a retrospective
           Sutent data collection. The primary endpoints of this study in patients with adv/mRCC
           are PFS and TTF for patients receiving Inlyta in 2nd line, and the combined PFS and TTF
           for patients receiving the Sutent-Inlyta sequence. In this non-interventional real life
           study, the objective is only descriptive and the sample size will rely on the precision
           of the estimate.
observational model: Other
time perspective: Other
measure: Progression-Free Survival (PFS)
time frame: 60 months
description: PFS for patients with adv/mRCC receiving Inlyta in 2nd line post Sutent is defined as the time from when the patient receives the first dose of Inlyta to the time of progression or death due to any cause, whichever occurs first
measure: Progression-Free Survival (PFS)
time frame: 60 months
description: Combined PFS for patients with adv/mRCC receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line, until progression or death due to any cause with Inlyta in 2nd line, whichever occurs first during the Sutent-Inlyta sequence
measure: Time to Treatment Failure (TTF)
time frame: 60 months
description: TTF for Inlyta 2nd line is defined as from when the patient receives the first dose of Inlyta to the time of Inlyta discontinuation (date completed by the physician).
measure: Time to Treatment Failure (TTF)
time frame: 60 months
description: TTF for the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician).
measure: Overall Response Rate (ORR)
time frame: 60 months
description: ORR for adv/mRCC patients receiving Inlyta in 2nd line post Sutent defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST criteria v1.1, relative to all patients who have baseline measurable disease.
measure: Overall Survival (OS)
time frame: 60 months
description: OS for adv/mRCC patients receiving Sutent in first line followed by Inlyta in 2nd line as measured from the date of first Sutent dose to the date of death of any cause.
measure: Time to strategy failure (TSF)
time frame: 60 months
description: TSF for patients receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician) without the time between discontinuation of Sutent and start of Inlyta.
measure: Dosing
time frame: 60 months
description: Description of real life usage of flexible dosing across Europe with description of treatment schedules (dosing change, dosing schedule, average dose received during the period treatment)
measure: Proportion of titrated patients
time frame: 60 months
description: A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks.
measure: Progression-Free Survival (PFS)
time frame: 60 months
description: PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent
measure: Efficacy
time frame: 60 months
description: Efficacy parameters (PFS, OS) for the combined 1st line Sutent - 2nd line sequences according to the second line post Sutent (other than Sutent-Inlyta)
measure: Safety
time frame: 60 months
description: Safety description with AE listing in patients receiving Inlyta
measure: QoL
time frame: 60 months
description: QoL using the Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19) questionnaire and the Mental Health (MH) and Role-Emotional (RE) domains of the SF-36 questionnaire.
arm group label: Observational Arm
description: Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. The possible sequences of treatment under investigation will be:
Sutent (prospective) - Inlyta
Sutent (retrospective) - Inlyta
Sutent - not further active treatment (supportive care)
Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus), other))
intervention type: Other
intervention name: observational
description: The study is non interventional. All drugs will be prescribed
arm group label: Observational Arm
other name: Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Austria
country: Belgium
country: France
country: Greece
country: Italy
country: Netherlands
country: Spain
country: United Kingdom
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061078&StudyName=Study%20Of%20The%20Impact%20Of%20Inlyta%20In%202nd%20Line%20On%20The%20Treatment%20Outcomes%20Of%20mRCC%20Patients%20Treated%20With%20Sutent%20In%201st%20Line%20In%20The%20Re
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Everolimus
mesh term: Temsirolimus
mesh term: Sorafenib
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
provided document: 
provided document: 