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

Metastatic Renal Cell Carcinoma (mRCC) Clinical Trial

— ADONIS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184416
• Other study ID #: A4061078
• Secondary ID: ADONIS
• Status: Completed
• Start date: October 31, 2014
• Est. completion date: September 30, 2022

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 573
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma (mRCC)

Intervention

Other:
• observational
The study is non interventional. All drugs will be prescribed

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Greece,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of titrated patients	A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks.	60 months
Secondary	Progression-Free Survival (PFS)	PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent	60 months
Secondary	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
Secondary	Safety	Safety description with AE listing in patients receiving Inlyta	60 months
Secondary	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

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