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
ADONIS
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)
2 other identifiers
observational
554
8 countries
110
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Longer than P75 for all trials
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedStudy Start
First participant enrolled
October 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedFebruary 27, 2026
February 1, 2026
7.9 years
July 2, 2014
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Progression-Free Survival (PFS)
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
60 months
Progression-Free Survival (PFS)
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
60 months
Time to Treatment Failure (TTF)
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).
60 months
Time to Treatment Failure (TTF)
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).
60 months
Secondary Outcomes (9)
Overall Response Rate (ORR)
60 months
Overall Survival (OS)
60 months
Time to strategy failure (TSF)
60 months
Dosing
60 months
Proportion of titrated patients
60 months
- +4 more secondary outcomes
Study Arms (1)
Observational Arm
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))
Interventions
The study is non interventional. All drugs will be prescribed
Eligibility Criteria
The study will enroll adv/mRCC patients when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment.
You may qualify if:
- Patient 18 years of age and over
- Histologically confirmed diagnosis of advanced/metastatic renal carcinoma (clear cell RCC as well as non-clear cell RCC) with measurable disease according to RECIST 1.1
- Patients being treated with Sutent in 1st line according to the European therapeutic indication and/or being treated with Inlyta in 2nd line according to the European approved therapeutic indication (except post cytokines)
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
You may not qualify if:
- Patients being treated with cytokines or any other treatment outside of Sutent in 1st line
- Patients receiving anti -tumor treatment beyond a second line
- Patients already under Sutent, already under Inlyta: enrolment must occur at the beginning of each line of treatment (before or at the first follow up visit at the latest)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (110)
Landeskrankenhaus Bregenz
Bregenz, A-6900, Austria
AKh Linz
Linz, 4021, Austria
Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie
Linz, A-4010, Austria
Krankenhaus Oberwart
Oberwart, 7400, Austria
Universitasklinik für Urologie und Andrologie
Salzburg, A-5020, Austria
AKH - Universitaetsklinik fuer Innere Medizin I
Vienna, 1090, Austria
AKH-Universitat Klinik fur Innere Medizin I
Vienna, 1090, Austria
Sozialmedizinisches Zentrum Ost
Vienna, 1220, Austria
ASZ Aalst - Campus Aalst
Aalst, 9300, Belgium
Imeldaziekenhuis
Bonheiden, 2820, Belgium
Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie
Ghent, 9000, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Clinique St Pierre - Oncologie
Ottignies, 1340, Belgium
Centre Antoine Lacassagne, Service d'Oncologie
Nice, Alpes-maritimes, 06189, France
Cl du Docteur Calabet / Cromg
Agen, 47000, France
CHU Angers - Hôpital Hôtel Dieu
Angers, 49100, France
Centre Hospitalier d'Auxerre
Auxerre, 89011, France
Institut Sainte Catherine, Department Oncologie, Medecine Interene
Avignon, 84082, France
Centre d'Oncologie et de Radiotherapie du pays Basque
Bayonne, 64100, France
Clinique Bordeaux Tivoli Ducos
Bordeaux, 33000, France
Hôpital Saint-André
Bordeaux, 33075, France
Institut Bergonie
Bordeaux, 33076, France
Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat
Bourg-en-Bresse, 1000, France
Centre Catalan Urologie Andrologie
Cabestany, 66330, France
C.H.G. Antoine Gayraud, Medecine Interne
Carcassonne, 11890, France
CH Rene Dubos
Cergy-Pontoise, 95303, France
Hopital Prive Sainte Marie
Chalon-sur-Saône, 71100, France
CHU Gabriel Montpied
Clermont-Ferrand, 63003, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Pole Sante Republique
Clermont-Ferrand, 63050, France
Centre d'Oncologie du Parc
Dijon, 21000, France
Clinique Clement Drevon
Dijon, 21000, France
Clinique Sainte Marguerite
Hyères, 83400, France
Hopital prive La Louviere
Lille, 59042, France
Hopital Dupuytren - Oncologie Medicale
Limoges, 87042, France
Centre Hospitalier de Longjumeau
Longjumeau, 91160, France
Clinique de la Sauvegarde
Lyon, 69337, France
Centre Hospitalier Prive Clairval
Marseille, 13274, France
Hopital Timone Adultes
Marseille, 13385, France
Hopital Nord
Marseille, 13915, France
Hopital Belle-Isle
Metz, 57045, France
Hopital Clinique Claude-Bernard
Metz, 57072, France
Groupe Hospitalier Intercommunal le Raincy Montfermeil
Montfermeil, 93370, France
Clinique Clémentville - Oncologie
Montpellier, 34070, France
Centre d'Oncologie de Gentilly
Nancy, 54100, France
Centre d'Oncology de Gentilly
Nancy, 54100, France
Hôpital Universitaire Carémeau
Nîmes, 30029, France
Centre Hospitalier de Pau
Pau, 64000, France
Polyclinique de Francheville
Périgueux, 24000, France
Centre Hospitalier Lyon Sud - Service d oncologie medicale
Pierre-Bénite, 69495, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CH Annecy Genevois
Pringy, 74374, France
CHR Annecy
Pringy, 74374, France
Institut Jean Godinot
Reims, 51056, France
Cl Armoricaine Radiologie / Radiotherapie
Saint-Brieuc, 22015, France
CHP Saint Gregoire
Saint-Grégoire, 35760, France
Centre Hospitalier Prive Saint Gregoire
Saint-Grégoire, 35768, France
Centre Rene Gauducheau - Service Oncologie Medicale
Saint-Herblain, 44805, France
Pôle Hospitalier Mutualiste
Saint-Nazaire, 44600, France
Groupe Hospitaier Sud Reunion
Saint-Pierre, 97410, France
Centre Hospitalier Sud Reunion
Saint-Pierre-des-Corps, 97449, France
Centre de Radiothérapie,
Strasbourg, 67010, France
Hopital de Hautepierre-Service Oncologie at Hematologie
Strasbourg, 67098, France
Hopital FOCH
Suresnes, 92151, France
Hopital Georges Pianta
Thonon-les-Bains, 74203, France
Hopital Sainte Musse
Toulon, 83000, France
Centre Hospitalier du Marechal Juin
Valence, 26000, France
Clinique les Dentellieres
Valenciennes, 59300, France
Hopital Jean BERNARD - Tours - 7eme etage
Valenciennes, 59300, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
General Hospital of Chest Diseases of Athens "Sotiria"
Athens, 11527, Greece
IRCC Oncologia Medica
Candiolo (TO), 10060, Italy
Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (FC), 47014, Italy
Istituto Nazionale Tumori, Oncologia Medica B
Milan, 20100, Italy
Divisione di Oncologia, AORN Antonio Cardarelli
Naples, 80131, Italy
Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale
Naples, 80131, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Viecuri Medical Centre
BL Venlo, 5912, Netherlands
Consorcio Hospitalario Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
A Coruña, 15006, Spain
Hospital Principe de Asturias
Alcalá de Henares, 28805, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Sant Pau
Barcelona, 08003, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
Hospital General Yague
Burgos, 09071, Spain
Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
Girona, 17007, Spain
Hospital de Leon
León, 24071, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Servicio de Oncologia Medica
Madrid, 28041, Spain
Hospital Morales Meseguer
Murcia, 30008, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital Virgen de La Salud
Toledo, 45004, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Salud Hospital Universitario Dr. Peset
Valencia, 46017, Spain
Centro Sanitario Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Centro Médico
Vigo, 36211, Spain
H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica
Vigo, 36312, Spain
Consultant Oncologist
Cheltenham, Gloustershire, GL53 7AN, United Kingdom
Kent & Canterbury Hospital
Canterbury, KENT, CT1, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Department of Cancer Medicine
Dundee, Tayside, DD1 9SY, United Kingdom
Royal United Hospital Bath NHS
Bath, BA1 3NG, United Kingdom
Department of Academic Oncology
Cottingham, HU16 5JQ, United Kingdom
Royal Marsden Hospital, Royal Marsden NHS Foundation Trust
London, SW3 7JJ, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 9, 2014
Study Start
October 31, 2014
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.