Clinical trial NCT02184416: 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
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma (mRCC)
Keywords: Inlyta
axitinib
Sutent
sunitinib
renal
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 573
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 60 months
measure: Progression-Free Survival (PFS)
timeFrame: 60 months
measure: Time to Treatment Failure (TTF)
timeFrame: 60 months
measure: Time to Treatment Failure (TTF)
timeFrame: 60 months
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 60 months
measure: Overall Survival (OS)
timeFrame: 60 months
measure: Time to strategy failure (TSF)
timeFrame: 60 months
measure: Dosing
timeFrame: 60 months
measure: Proportion of titrated patients
timeFrame: 60 months
measure: Progression-Free Survival (PFS)
timeFrame: 60 months
measure: Efficacy
timeFrame: 60 months
measure: Safety
timeFrame: 60 months
measure: QoL
timeFrame: 60 months
Other outcomes:
Locations:
city: Bregenz
country: Austria
facility: Landeskrankenhaus Bregenz
city: Linz
country: Austria
facility: AKh Linz
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie
city: Oberwart
country: Austria
facility: Krankenhaus Oberwart
city: Salzburg
country: Austria
facility: Universitasklinik für Urologie und Andrologie
city: Vienna
country: Austria
facility: AKH - Universitaetsklinik fuer Innere Medizin I
city: Wien
country: Austria
facility: AKH-Universitat Klinik fur Innere Medizin I
city: Wien
country: Austria
facility: Sozialmedizinisches Zentrum Ost
city: Aalst
country: Belgium
facility: ASZ Aalst - Campus Aalst
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Ottignies
country: Belgium
facility: Clinique St Pierre - Oncologie
city: Nice Cedex 2
country: France
facility: Centre Antoine Lacassagne, Service d'Oncologie
state: Alpes-maritimes
city: Agen
country: France
facility: Cl du Docteur Calabet / Cromg
city: Angers
country: France
facility: CHU Angers - Hôpital Hôtel Dieu
city: Auxerre Cedex
country: France
facility: Centre Hospitalier d'Auxerre
city: Avignon cedex 2
country: France
facility: Institut Sainte Catherine, Department Oncologie, Medecine Interene
city: Bayonne
country: France
facility: Centre d'Oncologie et de Radiotherapie du pays Basque
city: Bordeaux Cedex
country: France
facility: Hôpital Saint-André
city: Bordeaux Cedex
country: France
facility: Institut Bergonie
city: Bordeaux
country: France
facility: Clinique Bordeaux Tivoli Ducos
city: Bourg En Bresse Cedex
country: France
facility: Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat
city: Cabestany
country: France
facility: Centre Catalan Urologie Andrologie
city: Carcassonne CEDEX 9
country: France
facility: C.H.G. Antoine Gayraud, Medecine Interne
city: CERGY Pontoise
country: France
facility: CH Rene Dubos
city: Chalon sur Saone
country: France
facility: Hopital Prive Sainte Marie
city: Clermont Ferrand Cedex 1
country: France
facility: CHU Gabriel Montpied
city: Clermont Ferrand Cedex 2
country: France
facility: Pole Sante Republique
city: Clermont-Ferrand Cedex 1
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre d'Oncologie du Parc
city: Dijon
country: France
facility: Clinique Clement Drevon
city: Hyères
country: France
facility: Clinique Sainte Marguerite
city: Lille
country: France
facility: Hopital prive La Louviere
city: Limoges Cedex
country: France
facility: Hopital Dupuytren - Oncologie Medicale
city: Longjumeau
country: France
facility: Centre Hospitalier de Longjumeau
city: Lyon Cedex 09
country: France
facility: Clinique de la Sauvegarde
city: Marseille Cedex 20
country: France
facility: Hopital Nord
city: Marseille Cedex
country: France
facility: Centre Hospitalier Prive Clairval
city: Marseille Cedex
country: France
facility: Hopital Timone Adultes
city: Metz Cedex
country: France
facility: Hopital Clinique Claude-Bernard
city: Metz
country: France
facility: Hopital Belle-Isle
city: Montfermeil
country: France
facility: Groupe Hospitalier Intercommunal le Raincy Montfermeil
city: Montpellier
country: France
facility: Clinique Clémentville - Oncologie
city: Nancy
country: France
facility: Centre d'Oncologie de Gentilly
city: Nancy
country: France
facility: Centre d'Oncology de Gentilly
city: Nimes cedex 9
country: France
facility: Hôpital Universitaire Carémeau
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Perigueux
country: France
facility: Polyclinique de Francheville
city: Pierre Benite cedex
country: France
facility: Centre Hospitalier Lyon Sud - Service d oncologie medicale
city: Pierre-bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Pringy Cedex
country: France
facility: CH Annecy Genevois
city: Pringy Cedex
country: France
facility: CHR Annecy
city: Reims
country: France
facility: Institut Jean Godinot
city: Saint Gregoire Cedex
country: France
facility: Centre Hospitalier Prive Saint Gregoire
city: Saint Gregoire
country: France
facility: CHP Saint Gregoire
city: Saint Pierre
country: France
facility: Groupe Hospitaier Sud Reunion
city: Saint-Nazaire
country: France
facility: Pôle Hospitalier Mutualiste
city: St Brieuc
country: France
facility: Cl Armoricaine Radiologie / Radiotherapie
city: St Herblain Cedex
country: France
facility: Centre Rene Gauducheau - Service Oncologie Medicale
city: St PIERRE Cedex
country: France
facility: Centre Hospitalier Sud Reunion
city: Strasbourg
country: France
facility: Centre de Radiothérapie,
city: Strasbourg
country: France
facility: Hopital de Hautepierre-Service Oncologie at Hematologie
city: Suresnes Cedex
country: France
facility: Hopital FOCH
city: Thonon les bains
country: France
facility: Hopital Georges Pianta
city: Toulon
country: France
facility: Hopital Sainte Musse
city: Valence
country: France
facility: Centre Hospitalier du Marechal Juin
city: Valenciennes
country: France
facility: Clinique les Dentellieres
city: Valenciennes
country: France
facility: Hopital Jean BERNARD - Tours - 7eme etage
city: Vandoeuvre les Nancy
country: France
facility: Centre Alexis Vautrin
city: Athens
country: Greece
facility: General Hospital of Chest Diseases of Athens "Sotiria"
city: Candiolo (TO)
country: Italy
facility: IRCC Oncologia Medica
city: Meldola (FC)
country: Italy
facility: Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Milan
country: Italy
facility: Istituto Nazionale Tumori, Oncologia Medica B
city: Napoli
country: Italy
facility: Divisione di Oncologia, AORN Antonio Cardarelli
city: Napoli
country: Italy
facility: Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: BL Venlo
country: Netherlands
facility: Viecuri Medical Centre
city: Sabadell
country: Spain
facility: Consorcio Hospitalario Parc Tauli
state: Barcelona
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
city: Alcala de Henares
country: Spain
facility: Hospital Principe de Asturias
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Burgos
country: Spain
facility: Hospital General Yague
city: Gerona
country: Spain
facility: Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
city: Leon
country: Spain
facility: Hospital de Leon
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Servicio de Oncologia Medica
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Toledo
country: Spain
facility: Hospital Virgen de La Salud
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Salud Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: Centro Sanitario Hospital Universitario y Politecnico La Fe
city: Vigo
country: Spain
facility: Centro Médico
city: Vigo
country: Spain
facility: H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica
city: Cheltenham
country: United Kingdom
facility: Consultant Oncologist
state: Gloustershire
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital
state: Kent
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
city: Dundee
country: United Kingdom
facility: Department of Cancer Medicine
state: Tayside
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath NHS
city: Cottingham
country: United Kingdom
facility: Department of Academic Oncology
city: London
country: United Kingdom
facility: Royal Marsden Hospital, Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: