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JOURNAL ONKOLOGIE – STUDIE
ADONIS

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

Rekrutierend

NCT-Nummer:
NCT02184416

Studienbeginn:
Oktober 2014

Letztes Update:
11.06.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Renal Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Pfizer

Collaborator:
-

Studienleiter

Pfizer CT.gov Call Center
Study Director
Pfizer

Kontakt

Pfizer CT.gov Call Center
Kontakt:
Phone: 1-800-718-1021
E-Mail: ClinicalTrials.gov_Inquiries@pfizer.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 110)

Landeskrankenhaus Bregenz
A-6900 Bregenz
AustriaAktiv, nicht rekrutierend» Google-Maps
Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie
A-4010 Linz
AustriaAktiv, nicht rekrutierend» Google-Maps
Krankenhaus Oberwart
7400 Oberwart
AustriaAktiv, nicht rekrutierend» Google-Maps
Universitasklinik für Urologie und Andrologie
A-5020 Salzburg
AustriaAktiv, nicht rekrutierend» Google-Maps
AKH - Universitaetsklinik fuer Innere Medizin I
1090 Vienna
AustriaAktiv, nicht rekrutierend» Google-Maps
AKH-Universitat Klinik fur Innere Medizin I
1090 Wien
AustriaAktiv, nicht rekrutierend» Google-Maps
Sozialmedizinisches Zentrum Ost
1220 Wien
AustriaAktiv, nicht rekrutierend» Google-Maps
ASZ Aalst - Campus Aalst
9300 Aalst
BelgiumAktiv, nicht rekrutierend» Google-Maps
Imeldaziekenhuis
2820 Bonheiden
BelgiumAktiv, nicht rekrutierend» Google-Maps
Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie
9000 Gent
BelgiumAktiv, nicht rekrutierend» Google-Maps
AZ Maria Middelares
9000 Gent
BelgiumAktiv, nicht rekrutierend» Google-Maps
Clinique St Pierre - Oncologie
1340 Ottignies
BelgiumAktiv, nicht rekrutierend» Google-Maps
Centre Antoine Lacassagne, Service d'Oncologie
06189 Nice Cedex 2
FranceAktiv, nicht rekrutierend» Google-Maps
Cl du Docteur Calabet / Cromg
47000 Agen
FranceAktiv, nicht rekrutierend» Google-Maps
CHU Angers - Hôpital Hôtel Dieu
49100 Angers
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier d'Auxerre
89011 Auxerre Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Sainte Catherine, Department Oncologie, Medecine Interene
84082 Avignon cedex 2
FranceAktiv, nicht rekrutierend» Google-Maps
Centre d'Oncologie et de Radiotherapie du pays Basque
64100 Bayonne
FranceAktiv, nicht rekrutierend» Google-Maps
Hôpital Saint-André
33075 Bordeaux Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Bergonie
33076 Bordeaux Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Clinique Bordeaux Tivoli Ducos
33000 Bordeaux
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat
1000 Bourg En Bresse Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Catalan Urologie Andrologie
66330 Cabestany
FranceAktiv, nicht rekrutierend» Google-Maps
C.H.G. Antoine Gayraud, Medecine Interne
11890 Carcassonne CEDEX 9
FranceAktiv, nicht rekrutierend» Google-Maps
CH Rene Dubos
95303 CERGY Pontoise
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Prive Sainte Marie
71100 Chalon sur Saone
FranceAktiv, nicht rekrutierend» Google-Maps
CHU Gabriel Montpied
63003 Clermont Ferrand Cedex 1
FranceAktiv, nicht rekrutierend» Google-Maps
Pole Sante Republique
63050 Clermont Ferrand Cedex 2
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Jean Perrin
63011 Clermont-Ferrand Cedex 1
FranceAktiv, nicht rekrutierend» Google-Maps
Centre d'Oncologie du Parc
21000 Dijon
FranceAktiv, nicht rekrutierend» Google-Maps
Clinique Clement Drevon
21000 Dijon
FranceAktiv, nicht rekrutierend» Google-Maps
Clinique Sainte Marguerite
83400 Hyères
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital prive La Louviere
59042 Lille
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Dupuytren - Oncologie Medicale
87042 Limoges Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier de Longjumeau
91160 Longjumeau
FranceAktiv, nicht rekrutierend» Google-Maps
Clinique de la Sauvegarde
69337 Lyon Cedex 09
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Nord
13915 Marseille Cedex 20
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Prive Clairval
13274 Marseille Cedex
FranceRekrutierend» Google-Maps
Hopital Timone Adultes
13385 Marseille Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Clinique Claude-Bernard
57072 Metz Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Groupe Hospitalier Intercommunal le Raincy Montfermeil
93370 Montfermeil
FranceAktiv, nicht rekrutierend» Google-Maps
Clinique Clémentville - Oncologie
34070 Montpellier
FranceAktiv, nicht rekrutierend» Google-Maps
Centre d'Oncologie de Gentilly
54100 Nancy
FranceAktiv, nicht rekrutierend» Google-Maps
Centre d'Oncology de Gentilly
54100 Nancy
FranceAktiv, nicht rekrutierend» Google-Maps
Hôpital Universitaire Carémeau
30029 Nimes cedex 9
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier de Pau
64000 Pau
FranceAktiv, nicht rekrutierend» Google-Maps
Polyclinique de Francheville
24000 Perigueux
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Lyon Sud - Service d oncologie medicale
69495 Pierre Benite cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Lyon Sud
69495 Pierre-bénite
FranceAktiv, nicht rekrutierend» Google-Maps
CH Annecy Genevois
74374 Pringy Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Institut Jean Godinot
51056 Reims
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Prive Saint Gregoire
35768 Saint Gregoire Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
CHP Saint Gregoire
35760 Saint Gregoire
FranceAktiv, nicht rekrutierend» Google-Maps
Groupe Hospitaier Sud Reunion
97410 Saint Pierre
FranceAktiv, nicht rekrutierend» Google-Maps
Pôle Hospitalier Mutualiste
44600 Saint-Nazaire
FranceAktiv, nicht rekrutierend» Google-Maps
Cl Armoricaine Radiologie / Radiotherapie
22015 St Brieuc
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Rene Gauducheau - Service Oncologie Medicale
44805 St Herblain Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier Sud Reunion
97449 St PIERRE Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Centre de Radiothérapie,
67010 Strasbourg
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital de Hautepierre-Service Oncologie at Hematologie
67098 Strasbourg
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital FOCH
92151 Suresnes Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Georges Pianta
74203 Thonon les bains
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Sainte Musse
83000 Toulon
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Hospitalier du Marechal Juin
26000 Valence
FranceAktiv, nicht rekrutierend» Google-Maps
Clinique les Dentellieres
59300 Valenciennes
FranceAktiv, nicht rekrutierend» Google-Maps
Hopital Jean BERNARD - Tours - 7eme etage
59300 Valenciennes
FranceAktiv, nicht rekrutierend» Google-Maps
Centre Alexis Vautrin
54511 Vandoeuvre les Nancy
FranceAktiv, nicht rekrutierend» Google-Maps
General Hospital of Chest Diseases of Athens "Sotiria"
11527 Athens
GreeceAktiv, nicht rekrutierend» Google-Maps
Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
47014 Meldola (FC)
ItalyAktiv, nicht rekrutierend» Google-Maps
Istituto Nazionale Tumori, Oncologia Medica B
20100 Milan
ItalyAktiv, nicht rekrutierend» Google-Maps
Divisione di Oncologia, AORN Antonio Cardarelli
80131 Napoli
ItalyAktiv, nicht rekrutierend» Google-Maps
Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale
80131 Napoli
ItalyAktiv, nicht rekrutierend» Google-Maps
IRCCS Policlinico San Matteo
27100 Pavia
ItalyAktiv, nicht rekrutierend» Google-Maps
Consorcio Hospitalario Parc Tauli
08208 Sabadell
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Mutua Terrassa / Servicio de Oncología Médica
08221 Terrassa
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital de Navarra
31008 Pamplona
SpainAktiv, nicht rekrutierend» Google-Maps
Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
15006 A Coruña
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Principe de Asturias
28805 Alcala de Henares
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital General Universitario de Alicante
03010 Alicante
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Sant Pau
08003 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinic i Provincial de Barcelona
08036 Barcelona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital General Yague
09071 Burgos
SpainAktiv, nicht rekrutierend» Google-Maps
Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
17007 Gerona
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon
28007 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Infanta Leonor
28031 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinico San Carlos
28040 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Servicio de Oncologia Medica
28041 Madrid
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Morales Meseguer
30008 Murcia
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario de Salamanca
37007 Salamanca
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario de Canarias
38320 Santa Cruz de Tenerife
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Virgen de La Salud
45004 Toledo
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Salud Hospital Universitario Dr. Peset
46017 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
Centro Sanitario Hospital Universitario y Politecnico La Fe
46026 Valencia
SpainAktiv, nicht rekrutierend» Google-Maps
H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica
36312 Vigo
SpainAktiv, nicht rekrutierend» Google-Maps
Consultant Oncologist
GL53 7AN Cheltenham
United KingdomAktiv, nicht rekrutierend» Google-Maps
Kent & Canterbury Hospital
CT1 Canterbury
United KingdomAktiv, nicht rekrutierend» Google-Maps
Royal Surrey County Hospital
GU2 7XX Guildford
United KingdomAktiv, nicht rekrutierend» Google-Maps
Department of Cancer Medicine
DD1 9SY Dundee
United KingdomAktiv, nicht rekrutierend» Google-Maps
Royal United Hospital Bath NHS
BA1 3NG Bath
United KingdomAktiv, nicht rekrutierend» Google-Maps
Department of Academic Oncology
HU16 5JQ Cottingham
United KingdomAktiv, nicht rekrutierend» Google-Maps
Royal Marsden Hospital, Royal Marsden NHS Foundation Trust
SW3 7JJ London
United KingdomAktiv, nicht rekrutierend» Google-Maps
Christie Hospital NHS Trust
M20 4BX Manchester
United KingdomAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) (Time Frame - 60 months):
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

2. Progression-Free Survival (PFS) (Time Frame - 60 months):
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

3. Time to Treatment Failure (TTF) (Time Frame - 60 months):
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).

4. Time to Treatment Failure (TTF) (Time Frame - 60 months):
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).

Secondary outcome:

1. Overall Response Rate (ORR) (Time Frame - 60 months):
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.

2. Overall Survival (OS) (Time Frame - 60 months):
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.

3. Time to strategy failure (TSF) (Time Frame - 60 months):
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.

4. Dosing (Time Frame - 60 months):
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)

5. Proportion of titrated patients (Time Frame - 60 months):
A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks.

6. Progression-Free Survival (PFS) (Time Frame - 60 months):
PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent

7. Efficacy (Time Frame - 60 months):
Efficacy parameters (PFS, OS) for the combined 1st line Sutent - 2nd line sequences according to the second line post Sutent (other than Sutent-Inlyta)

8. Safety (Time Frame - 60 months):
Safety description with AE listing in patients receiving Inlyta

9. QoL (Time Frame - 60 months):
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.

Geprüfte Regime

  • observational (Nexavar (sorafenib), Votreint (pazopanib), Afinitor (everolimus), Torisel (temsirolimus)):
    The study is non interventional. All drugs will be prescribed

Quelle: ClinicalTrials.gov


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