AzTrials
AzTrials

Metastatic Renal Cell Carcinoma (mRCC)ADONISNCT02184416

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

An observational study of Metastatic Renal Cell Carcinoma (mRCC), run by Pfizer at 110 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Renal Cell Carcinoma (mRCC)
What is being tested?
observational
How many people
554 participants
Where
110 sitesin 8 countries
Study dates
31 Oct 2014to 30 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

110 sites in 8 countries.

110 sites in 8 countries

France57 sites

  • Cl du Docteur Calabet / Cromg

    Agen, 47000

  • CHU Angers - Hôpital Hôtel Dieu

    Angers, 49100

  • Centre Hospitalier d'Auxerre

    Auxerre, 89011

  • Institut Sainte Catherine, Department Oncologie, Medecine Interene

    Avignon, 84082

  • Centre d'Oncologie et de Radiotherapie du pays Basque

    Bayonne, 64100

  • Clinique Bordeaux Tivoli Ducos

    Bordeaux, 33000

  • Hôpital Saint-André

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat

    Bourg-en-Bresse, 1000

  • Centre Catalan Urologie Andrologie

    Cabestany, 66330

  • C.H.G. Antoine Gayraud, Medecine Interne

    Carcassonne, 11890

  • CH Rene Dubos

    Cergy-Pontoise, 95303

  • Hopital Prive Sainte Marie

    Chalon-sur-Saône, 71100

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63003

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Pole Sante Republique

    Clermont-Ferrand, 63050

  • Centre d'Oncologie du Parc

    Dijon, 21000

  • Clinique Clement Drevon

    Dijon, 21000

  • Clinique Sainte Marguerite

    Hyères, 83400

  • Hopital prive La Louviere

    Lille, 59042

  • Hopital Dupuytren - Oncologie Medicale

    Limoges, 87042

  • Centre Hospitalier de Longjumeau

    Longjumeau, 91160

  • Clinique de la Sauvegarde

    Lyon, 69337

  • Centre Hospitalier Prive Clairval

    Marseille, 13274

  • Hopital Timone Adultes

    Marseille, 13385

  • Hopital Nord

    Marseille, 13915

  • Hopital Belle-Isle

    Metz, 57045

  • Hopital Clinique Claude-Bernard

    Metz, 57072

  • Groupe Hospitalier Intercommunal le Raincy Montfermeil

    Montfermeil, 93370

  • Clinique Clémentville - Oncologie

    Montpellier, 34070

  • Centre d'Oncologie de Gentilly

    Nancy, 54100

  • Centre d'Oncology de Gentilly

    Nancy, 54100

  • Centre Antoine Lacassagne, Service d'Oncologie

    Nice, Alpes-maritimes, 06189

  • Hôpital Universitaire Carémeau

    Nîmes, 30029

  • Centre Hospitalier de Pau

    Pau, 64000

  • Polyclinique de Francheville

    Périgueux, 24000

  • Centre Hospitalier Lyon Sud - Service d oncologie medicale

    Pierre-Bénite, 69495

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CH Annecy Genevois

    Pringy, 74374

  • CHR Annecy

    Pringy, 74374

  • Institut Jean Godinot

    Reims, 51056

  • Cl Armoricaine Radiologie / Radiotherapie

    Saint-Brieuc, 22015

  • CHP Saint Gregoire

    Saint-Grégoire, 35760

  • Centre Hospitalier Prive Saint Gregoire

    Saint-Grégoire, 35768

  • Centre Rene Gauducheau - Service Oncologie Medicale

    Saint-Herblain, 44805

  • Pôle Hospitalier Mutualiste

    Saint-Nazaire, 44600

  • Groupe Hospitaier Sud Reunion

    Saint-Pierre, 97410

  • Centre Hospitalier Sud Reunion

    Saint-Pierre-des-Corps, 97449

  • Centre de Radiothérapie,

    Strasbourg, 67010

  • Hopital de Hautepierre-Service Oncologie at Hematologie

    Strasbourg, 67098

  • Hopital FOCH

    Suresnes, 92151

  • Hopital Georges Pianta

    Thonon-les-Bains, 74203

  • Hopital Sainte Musse

    Toulon, 83000

  • Centre Hospitalier du Marechal Juin

    Valence, 26000

  • Clinique les Dentellieres

    Valenciennes, 59300

  • Hopital Jean BERNARD - Tours - 7eme etage

    Valenciennes, 59300

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain24 sites

  • Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera

    A Coruña, 15006

  • Hospital Principe de Asturias

    Alcalá de Henares, 28805

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Sant Pau

    Barcelona, 08003

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital General Yague

    Burgos, 09071

  • Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

  • Hospital de Leon

    León, 24071

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Infanta Leonor

    Madrid, 28031

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Servicio de Oncologia Medica

    Madrid, 28041

  • Hospital Morales Meseguer

    Murcia, 30008

  • Hospital de Navarra

    Pamplona, Navarre, 31008

  • Consorcio Hospitalario Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Virgen de La Salud

    Toledo, 45004

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Salud Hospital Universitario Dr. Peset

    Valencia, 46017

  • Centro Sanitario Hospital Universitario y Politecnico La Fe

    Valencia, 46026

  • Centro Médico

    Vigo, 36211

  • H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica

    Vigo, 36312

Other trials in Spain

Austria8 sites

  • Landeskrankenhaus Bregenz

    Bregenz, A-6900

  • AKh Linz

    Linz, 4021

  • Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie

    Linz, A-4010

  • Krankenhaus Oberwart

    Oberwart, 7400

  • Universitasklinik für Urologie und Andrologie

    Salzburg, A-5020

  • AKH - Universitaetsklinik fuer Innere Medizin I

    Vienna, 1090

  • AKH-Universitat Klinik fur Innere Medizin I

    Vienna, 1090

  • Sozialmedizinisches Zentrum Ost

    Vienna, 1220

Other trials in Austria

United Kingdom8 sites

  • Royal United Hospital Bath NHS

    Bath, BA1 3NG

  • Kent & Canterbury Hospital

    Canterbury, KENT, CT1

  • Consultant Oncologist

    Cheltenham, Gloustershire, GL53 7AN

  • Department of Academic Oncology

    Cottingham, HU16 5JQ

  • Department of Cancer Medicine

    Dundee, Tayside, DD1 9SY

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • Royal Marsden Hospital, Royal Marsden NHS Foundation Trust

    London, SW3 7JJ

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Italy6 sites

  • IRCC Oncologia Medica

    Candiolo (TO), 10060

  • Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola (FC), 47014

  • Istituto Nazionale Tumori, Oncologia Medica B

    Milan, 20100

  • Divisione di Oncologia, AORN Antonio Cardarelli

    Naples, 80131

  • Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale

    Naples, 80131

  • IRCCS Policlinico San Matteo

    Pavia, 27100

Other trials in Italy

Belgium5 sites

  • ASZ Aalst - Campus Aalst

    Aalst, 9300

  • Imeldaziekenhuis

    Bonheiden, 2820

  • Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie

    Ghent, 9000

  • AZ Maria Middelares

    Ghent, 9000

  • Clinique St Pierre - Oncologie

    Ottignies, 1340

Other trials in Belgium

Greece1 site

  • General Hospital of Chest Diseases of Athens "Sotiria"

    Athens, 11527

Other trials in Greece

Netherlands1 site

  • Viecuri Medical Centre

    BL Venlo, 5912

Other trials in Netherlands

About this study

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)

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.

Read the 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.
Being tested
observational
Keywords
Inlyta, axitinib, Sutent, sunitinib, renal
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observationalOther

    Also called Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus)

    The study is non interventional. All drugs will be prescribed

Study groups in NCT02184416
Study groupRoleWhat they receive
Observational ArmPatients 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))
Receives: Other: observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 60 months

  2. 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

    Measured: 60 months

  3. 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).

    Measured: 60 months

  4. 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).

    Measured: 60 months

Secondary outcomes (9)

  1. 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.

    Measured: 60 months

  2. 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.

    Measured: 60 months

  3. 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.

    Measured: 60 months

  4. 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)

    Measured: 60 months

  5. Proportion of titrated patients

    A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks.

    Measured: 60 months

  6. Progression-Free Survival (PFS)

    PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent

    Measured: 60 months

  7. 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)

    Measured: 60 months

  8. Safety

    Safety description with AE listing in patients receiving Inlyta

    Measured: 60 months

  9. 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.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2014 (estimated)
  2. Study start31 Oct 2014
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02184416
Sponsor's protocol ID
A4061078
Other IDs
ADONIS
Acronym
ADONIS
Status last verified
Feb 2026
First submitted
2 Jul 2014
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Renal Cell Carcinoma (mRCC), run by Pfizer at 110 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in France, Spain, Austria, United Kingdom, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 60 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02184416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in