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)

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Renal Cell Carcinoma (mRCC)
• Intervention / Treatment: Other: observational

Detailed 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)) 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.

• Study Type: Observational
• Enrollment (Actual): 554

Contacts and Locations

Study Locations

• Austria
  • Bregenz, Austria, A-6900
    • Landeskrankenhaus Bregenz
  • Linz, Austria, 4021
    • AKh Linz
  • Linz, Austria, A-4010
    • Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie
  • Oberwart, Austria, 7400
    • Krankenhaus Oberwart
  • Salzburg, Austria, A-5020
    • Universitasklinik für Urologie und Andrologie
  • Vienna, Austria, 1090
    • AKH - Universitaetsklinik fuer Innere Medizin I
  • Vienna, Austria, 1090
    • AKH-Universitat Klinik fur Innere Medizin I
  • Vienna, Austria, 1220
    • Sozialmedizinisches Zentrum Ost
• Belgium
  • Aalst, Belgium, 9300
    • ASZ Aalst - Campus Aalst
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis
  • Ghent, Belgium, 9000
    • AZ Maria Middelares
  • Ghent, Belgium, 9000
    • Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie
  • Ottignies, Belgium, 1340
    • Clinique St Pierre - Oncologie
• France
  • Agen, France, 47000
    • Cl du Docteur Calabet / Cromg
  • Angers, France, 49100
    • CHU Angers - Hôpital Hôtel Dieu
  • Auxerre, France, 89011
    • Centre Hospitalier d'Auxerre
  • Avignon, France, 84082
    • Institut Sainte Catherine, Department Oncologie, Medecine Interene
  • Bayonne, France, 64100
    • Centre d'Oncologie et de Radiotherapie du pays Basque
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Bordeaux, France, 33075
    • Hôpital Saint-André
  • Bordeaux, France, 33000
    • Clinique Bordeaux Tivoli Ducos
  • Bourg-en-Bresse, France, 1000
    • Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat
  • Cabestany, France, 66330
    • Centre Catalan Urologie Andrologie
  • Carcassonne, France, 11890
    • C.H.G. Antoine Gayraud, Medecine Interne
  • Cergy-Pontoise, France, 95303
    • CH René Dubos
  • Chalon-sur-Saône, France, 71100
    • Hôpital privé sainte Marie
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Clermont-Ferrand, France, 63003
    • Chu Gabriel Montpied
  • Clermont-Ferrand, France, 63050
    • Pôle Santé République
  • Dijon, France, 21000
    • Centre d'Oncologie du Parc
  • Dijon, France, 21000
    • Clinique Clement Drevon
  • Hyères, France, 83400
    • Clinique Sainte Marguerite
  • Lille, France, 59042
    • Hôpital privé La Louvière
  • Limoges, France, 87042
    • Hopital Dupuytren - Oncologie Medicale
  • Longjumeau, France, 91160
    • Centre Hospitalier de Longjumeau
  • Lyon, France, 69337
    • Clinique de la Sauvegarde
  • Marseille, France, 13915
    • Hôpital Nord
  • Marseille, France, 13385
    • Hopital Timone Adultes
  • Marseille, France, 13274
    • Centre Hospitalier Prive Clairval
  • Metz, France, 57045
    • Hopital Belle-Isle
  • Metz, France, 57072
    • Hopital Clinique Claude-Bernard
  • Montfermeil, France, 93370
    • Groupe Hospitalier Intercommunal le Raincy Montfermeil
  • Montpellier, France, 34070
    • Clinique Clémentville - Oncologie
  • Nancy, France, 54100
    • Centre d'oncologie de Gentilly
  • Nancy, France, 54100
    • Centre d'Oncology de Gentilly
  • Nîmes, France, 30029
    • Hopital Universitaire Caremeau
  • Pau, France, 64000
    • Centre Hospitalier de Pau
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud - Service d oncologie medicale
  • Pringy, France, 74374
    • Ch Annecy Genevois
  • Pringy, France, 74374
    • CHR Annecy
  • Périgueux, France, 24000
    • Polyclinique de Francheville
  • Reims, France, 51056
    • Institut Jean Godinot
  • Saint-Brieuc, France, 22015
    • Cl Armoricaine Radiologie / Radiotherapie
  • Saint-Grégoire, France, 35760
    • CHP Saint Grégoire
  • Saint-Grégoire, France, 35768
    • Centre Hospitalier Privé Saint Grégoire
  • Saint-Herblain, France, 44805
    • Centre Rene Gauducheau - Service Oncologie Medicale
  • Saint-Nazaire, France, 44600
    • Pôle Hospitalier Mutualiste
  • Saint-Pierre, France, 97410
    • Groupe Hospitaier Sud Reunion
  • Saint-Pierre-des-Corps, France, 97449
    • Centre Hospitalier Sud Reunion
  • Strasbourg, France, 67010
    • Centre de Radiothérapie,
  • Strasbourg, France, 67098
    • Hopital de Hautepierre-Service Oncologie at Hematologie
  • Suresnes, France, 92151
    • Hopital Foch
  • Thonon-les-Bains, France, 74203
    • Hôpital Georges PIANTA
  • Toulon, France, 83000
    • Hôpital Sainte Musse
  • Valence, France, 26000
    • Centre Hospitalier du Marechal Juin
  • Valenciennes, France, 59300
    • Clinique les Dentellieres
  • Valenciennes, France, 59300
    • Hopital Jean BERNARD - Tours - 7eme etage
  • Vandœuvre-lès-Nancy, France, 54511
    • Centre Alexis Vautrin
  • Alpes-maritimes
    • Nice, Alpes-maritimes, France, 06189
      • Centre Antoine Lacassagne, Service d'Oncologie
• Greece
  • Athens, Greece, 11527
    • General Hospital of Chest Diseases of Athens "Sotiria"
• Italy
  • Candiolo (TO), Italy, 10060
    • IRCC Oncologia Medica
  • Meldola (FC), Italy, 47014
    • Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Milan, Italy, 20100
    • Istituto Nazionale Tumori, Oncologia Medica B
  • Napoli, Italy, 80131
    • Divisione di Oncologia, AORN Antonio Cardarelli
  • Napoli, Italy, 80131
    • Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale
  • Pavia, Italy, 27100
    • IRCCS Policlinico San Matteo
• Netherlands
  • BL Venlo, Netherlands, 5912
    • Viecuri Medical Centre
• Spain
  • A Coruña, Spain, 15006
    • Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
  • Alcalá de Henares, Spain, 28805
    • Hospital Príncipe de Asturias
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Barcelona, Spain, 08003
    • Hospital Sant Pau
  • Burgos, Spain, 09071
    • Hospital General Yague
  • Girona, Spain, 17007
    • Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
  • León, Spain, 24071
    • Hospital de Leon
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28031
    • Hospital Infanta Leonor
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28041
    • Servicio de Oncologia Medica
  • Murcia, Spain, 30008
    • Hospital Morales Meseguer
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Santa Cruz de Tenerife, Spain, 38320
    • Hospital Universitario de Canarias
  • Toledo, Spain, 45004
    • Hospital Virgen de la Salud
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46017
    • Salud Hospital Universitario Dr. Peset
  • Valencia, Spain, 46026
    • Centro Sanitario Hospital Universitario y Politecnico La Fe
  • Vigo, Spain, 36211
    • Centro Médico
  • Vigo, Spain, 36312
    • H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Consorcio Hospitalario Parc Tauli
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Hospital de Navarra
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital Bath NHS
  • Cottingham, United Kingdom, HU16 5JQ
    • Department of Academic Oncology
  • London, United Kingdom, SW3 7JJ
    • Royal Marsden Hospital, Royal Marsden NHS Foundation Trust
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital NHS Trust
  • Gloustershire
    • Cheltenham, Gloustershire, United Kingdom, GL53 7AN
      • Consultant Oncologist
  • KENT
    • Canterbury, KENT, United Kingdom, CT1
      • Kent & Canterbury Hospital
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XX
      • Royal Surrey County Hospital
  • Tayside
    • Dundee, Tayside, United Kingdom, DD1 9SY
      • Department of Cancer Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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))

Other: observational; The study is non interventional. All drugs will be prescribed; Other Names: Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	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.	60 months
Overall Survival (OS)	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.	60 months
Time to strategy failure (TSF)	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.	60 months
Dosing	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)	60 months
Proportion of titrated patients	A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks.	60 months
Progression-Free Survival (PFS)	PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent	60 months
Efficacy	Efficacy parameters (PFS, OS) for the combined 1st line Sutent - 2nd line sequences according to the second line post Sutent (other than Sutent-Inlyta)	60 months
Safety	Safety description with AE listing in patients receiving Inlyta	60 months
QoL	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.	60 months

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2014
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 3, 2014
• First Posted (Estimated): July 9, 2014

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: sunitinib; renal; axitinib; Sutent; Inlyta
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell; Health Services Administration; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Quality of Health Care; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Macrolides; Lactones; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Sirolimus; Urea; Acids, Heterocyclic; Phenylurea Compounds; Niacinamide; Nicotinic Acids; Sorafenib; Everolimus; Watchful Waiting; temsirolimus; pazopanib
• Other Study ID Numbers: A4061078; ADONIS (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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.