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JOURNAL ONKOLOGIE – STUDIE
CABOCARE

Study of Cabozantinib in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.

Rekrutierend

NCT-Nummer:
NCT03647878

Studienbeginn:
September 2018

Letztes Update:
24.02.2021

Wirkstoff:
-

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Ipsen

Collaborator:
-

Studienleiter

Ipsen Medical Director
Study Director
Ipsen

Kontakt

Studienlocations
(3 von 42)

Onkologie aschaffenburg
63739 Aschaffenburg
(Bayern)
GermanyRekrutierend» Google-Maps
Klinikum am Bruderwald Medizinische Klinik V
96049 Bamberg
(Bayern)
GermanyRekrutierend» Google-Maps
Praxis für Urologie
12099 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
Onkologie am Segelfliegerdamm
12487 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
überörtl. Praxis für Urologie & Onkologie
13055 Berlin
(Berlin)
GermanyAktiv, nicht rekrutierend» Google-Maps
Brustzentrum Franziskus Hospital Bielefeld
Kiskerstraße 26
33615 Bielefeld, Stadt
DeutschlandAktiv, nicht rekrutierend» Google-Maps
Centrum für Operative Urologie
28277 Bremen
(Bremen)
GermanyRekrutierend» Google-Maps
Edia.med MVZ
09130 Chemnitz
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Onkologisches Zentrum Donauwörth
86609 Donauwörth
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Onkozentrum Dresden/Freiberg
01127 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Urologische Gemeinschaftspraxis
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
St. Georg Klinikum
99817 Eisenach
(Thüringen)
GermanyRekrutierend» Google-Maps
Universitatmedizin Göttingen
37075 Göttingen
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Evangelisches Krankenhaus Hamm gGmbH
59063 Hamm
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Onkologisches Studienzentrum am Raschplatz
30161 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Immunologisch onkologisches MVZ
30449 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Praxis für Hämatologie, Onkologie und Gerinnung
96317 Kronach
(Bayern)
GermanyRekrutierend» Google-Maps
Urologische Arztpraxis
06295 Lutherstadt Eisleben
(Sachsen-Anhalt)
GermanyAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Magdeburg
39120 Magdeburg
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Praxis für Urologie, Andrologie, Onkologie und medikamentöse Tumortherapie
04416 Markkleeberg
(Sachsen)
GermanyRekrutierend» Google-Maps
Urologische Gemeischaftspraxis Hochsauerland
59872 Meschede
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Onkologische Praxis Moers
47441 Moers
(Nordrhein-Westfalen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Darmzentrum der Kliniken Maria Hilf GmbH Mönchengladbach
Sandradstraße 43
41061 Mönchengladbach
DeutschlandAktiv, nicht rekrutierend» Google-Maps
Facharztpraxis für Hämatologie und Internistische Onkologie
80331 München
(Bayern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandRekrutierend» Google-Maps
Praxis für Hämatologie und Internistische Onkologie
31535 Neustadt Am Rübenberge
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Interdisziplinäres Brustzentrum Klinikum Nürnberg
Prof.-Ernst-Nathan-Straße 1
90419 Nürnberg
(Bayern)
DeutschlandRekrutierend» Google-Maps
MVZ Kreis Olpe
57462 Olpe
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Darmkrebszentrum im Brüderkrankenhaus St. Josef Paderborn
Husener Straße 46
33098 Paderborn
DeutschlandRekrutierend» Google-Maps
Urologische Praxis
19370 Parchim
(Mecklenburg-Vorpommern)
GermanyAktiv, nicht rekrutierend» Google-Maps
Elblandklinikum Riesa
01589 Riesa
(Sachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Wissenschaftskontor Nord GmbH &Co KG
18107 Rostock
(Mecklenburg-Vorpommern)
GermanyAktiv, nicht rekrutierend» Google-Maps
MVZ MP Saaletal
07318 Saalfeld/Saale
(Thüringen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Klinikum Sindelfingen-Böblingen
71065 Sindelfingen
(Baden-Württemberg)
GermanyAktiv, nicht rekrutierend» Google-Maps
Darmzentrum am Krankenhaus der Barmherzigen Brüder Trier
Nordallee 1
54292 Trier
DeutschlandAktiv, nicht rekrutierend» Google-Maps
Medizinische Studiengesellschaft Nord-West GmbH
26655 Westerstede
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Praxisgemeinschaft für Onkologie und Urologie
26389 Wilhelmshaven
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
GIM - Gemeinschaftspraxis Innere Medizin
58455 Witten
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Onkologische Schwerpunktpraxis Wolfsburg
38440 Wolfsburg
(Niedersachsen)
GermanyAktiv, nicht rekrutierend» Google-Maps
Landeskrankenhaus Hochsteiermark
A-8700 Leoben
AustriaAktiv, nicht rekrutierend» Google-Maps
Salzkammergutklinikum Vöcklabruck
A-4840 Vöcklabruck
AustriaAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of the protocol, is to describe the use of CabometyxTM (cabozantinib) tablets

including the number of dose reductions, dose interruptions and terminations due to (serious)

adverse events in subjects with advanced or metastatic renal cell carcinoma (mRCC) treated in

real-life clinical setting in 1st line treatment.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Males or females aged 18 years and older with capacity to consent.

- Subjects receiving cabozantinib as a first line treatment for advanced or metastatic

renal cell carcinoma

- Subjects with the intention to be treated with cabozantinib tablets according to the

current local Summary of Product Characteristics (SmPC) (Germany, Austria); decision

has to be taken before entry in the study.

- Signed written informed consent

Exclusion Criteria:

- Participation in an interventional study at the same time and/or within 3 months

before baseline.

- Previous participation in this study

Studien-Rationale

Primary outcome:

1. The proportion of subjects with dose reduction due to Serious Adverse Events/Adverse Events (SAEs/AEs) (Time Frame - 2 years):
The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall.

2. The proportion of subjects with dose interruption due to SAEs/AEs (Time Frame - 2 years):
The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall.

3. The proportion of subjects with termination of Cabozantinib due to SAEs/AEs (Time Frame - 2 years):
The proportion of subjects with ≥1 discontinuation due to AE will be described with its 95% confidence interval, by risk group and overall.

Secondary outcome:

1. Progression free survival (PFS) (Time Frame - 2 years):
Progression free survival is defined as the time between the start date of cabozantinib and the date of progression or death from any cause. Disease progression is defined as either radiological progression assessed by the investigator using RECIST 1.1 or clinical progression.

2. Best overall response - Overall Response Rate (ORR) (Time Frame - 2 years):
The best overall response is the best response assessed by investigator recorded during the treatment period. ORR is defined as the proportion of subjects achieving complete or partial response.

3. Best overall response - Disease Control Rate (DCR) (Time Frame - 2 years):
The best overall response is the best response assessed by investigator recorded during the treatment period. DCR is defined as the proportion of subjects achieving a complete response, partial response or stable disease.

4. All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes (Time Frame - 2 years):
Safety: clinical parameter, as routinely assessed by the investigator, as well as occurrence of all serious and non-serious AEs as well as fatal outcomes and special situations. The adverse events will be described overall and also according to level of physical activity assessed by questionnaire and actigraph.

5. Impact of the activity level at baseline on the occurrence of adverse events (AEs) (Time Frame - 2 years):
Safety: clinical parameter, as routinely assessed by the investigator, as well as occurrence of all serious and non-serious AEs as well as fatal outcomes and special situations; data of activity level and quality of life will be collected using the quality of life questionnaire (NFKSI-19 questionnaire) and the activity questionnaire; inflammatory blood markers, as routinely assessed by the investigator, will be captured.

6. The proportion of subjects with termination due to SAEs/AEs in sub-group (Time Frame - 2 year):
The proportion of subjects with ≥1 termination due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).

7. The proportion of subjects with dose interruption due to SAEs/AEs in sub-group (Time Frame - 2 year):
The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).

8. The proportion of subjects with dose reduction due to SAEs/AEs in sub-group (Time Frame - 2 years):
The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall split by histological subtype (clear cell and non-clear cell).

Quelle: ClinicalTrials.gov


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