JOURNAL ONKOLOGIE – STUDIE
An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer
Rekrutierend
NCT-Nummer:
NCT02365597
Studienbeginn:
April 2015
Letztes Update:
30.12.2020
Wirkstoff:
Erdafitinib, Midazolam, Metformin
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
Janssen Research & Development, LLC
Collaborator:
-
Studienleiter
Study Director
Janssen Research & Development, LLC
Kontakt
Kontakt:
E-Mail: JNJ.CT@sylogent.com» Kontaktdaten anzeigen
Studienlocations (3 von 147)
Darmzentrum am Krankenhaus der Barmherzigen Brüder Trier
Nordallee 1
54292 Trier
DeutschlandAbgeschlossen» Google-MapsVivantes Klinikum Am Urban, Abt. fur Kardiologie
10967 Berlin
(Berlin)
GermanyAbgeschlossen» Google-MapsWaldkrankenhaus St. Marien -Urologische Universitätsklinik-
91054 Erlangen
(Bayern)
GermanyAbgeschlossen» Google-Maps
Nordallee 1
54292 Trier
DeutschlandAbgeschlossen» Google-MapsVivantes Klinikum Am Urban, Abt. fur Kardiologie
10967 Berlin
(Berlin)
GermanyAbgeschlossen» Google-MapsWaldkrankenhaus St. Marien -Urologische Universitätsklinik-
91054 Erlangen
(Bayern)
GermanyAbgeschlossen» Google-Maps
Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
45136 Essen
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-MapsGoethe Universität Frankfurt
60590 Frankfurt
(Hessen)
GermanyZurückgezogen» Google-MapsUniversitatsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-MapsInterdisziplinäres Brustzentrum der Universitätsmedizin Greifswald
Ferdinand-Sauerbruch-Straße
17475 Greifswald Greifswald
(Mecklenburg-Vorpommern)
DeutschlandAbgeschlossen» Google-MapsGeorg-August-Universitaet Goettingen - Innere Medizin - Haematologie, Onkologie
37075 Göttingen
(Niedersachsen)
GermanyAbgeschlossen» Google-MapsAsklepios Klinik Altona
22763 Hamburg
(Hamburg)
GermanyAbgeschlossen» Google-MapsMedizinische Hochschule Hannover;Klinik f. Urologie u. Urologische Onkologie
30625 Hannover
(Niedersachsen)
GermanyAbgeschlossen» Google-MapsUniversity Hospital Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-MapsKlinikum rechts der Isar der TU Muenchen
81675 Muenchen
(Bayern)
GermanyAbgeschlossen» Google-MapsUniversity hospital Muenster, Dpt. of Urology
48129 Muenster
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-MapsCaritas Krankenhaus St. Josef - Innere Medizin II
93053 Regensburg
(Bayern)
GermanyAbgeschlossen» Google-MapsGynäkologisches Krebszentrum am Klinikum St. Elisabeth Straubing
St.-Elisabeth-Straße 23
94315 Straubing
DeutschlandAbgeschlossen» Google-MapsKliniken Nordoberpfalz, Klinik für Urologie
92637 Weiden/Opf
(Bayern)
GermanyAbgeschlossen» Google-MapsMayo Clinic Arizona
85259 Scottsdale
United StatesZurückgezogen» Google-MapsArizona Oncology Associates, PC - NAHOA
86336 Sedona
United StatesAbgeschlossen» Google-MapsUniversity of Arizona Cancer Center
85724 Tucson
United StatesZurückgezogen» Google-MapsMarin Cancer Care Inc.
94904 Greenbrae
United StatesZurückgezogen» Google-MapsCedars Sinai Medical Center - Pediatric Infectious Disease
90048 Los Angeles
United StatesZurückgezogen» Google-MapsRonald Reagan UCLA Medical Center
90095 Los Angeles
United StatesAbgeschlossen» Google-MapsUniversity of California Irvine
92868 Orange
United StatesZurückgezogen» Google-MapsUniversity of California - Davis Medical Center
95817 Sacramento
United StatesAbgeschlossen» Google-MapsStanford University Medical Center
94305 Stanford
United StatesAbgeschlossen» Google-MapsRocky Mountain Cancer Center
80012 Aurora
United StatesAbgeschlossen» Google-MapsGeorgetown Univ. Medical Center - Lombardi Cancer Center
20007 Washington
United StatesAbgeschlossen» Google-MapsNorthwestern University Feinberg School of Medicine
60611 Chicago
United StatesZurückgezogen» Google-MapsUniversity of Chicago
60637 Chicago
United StatesAbgeschlossen» Google-MapsThe University of Iowa - Division of Hematology, Oncology and Blood & Marrow Transplantation
52242 Iowa City
United StatesAbgeschlossen» Google-MapsNorton Cancer Institute
40202 Louisville
United StatesAbgeschlossen» Google-MapsUniv of Michigan Medical Center
48109 Ann Arbor
United StatesZurückgezogen» Google-MapsKarmanos Cancer Institute - Wayne State University
48201 Detroit
United StatesZurückgezogen» Google-MapsMinnesota Oncology
55404 Minneapolis
United StatesAbgeschlossen» Google-MapsNebraska Cancer Specialists
68130 Omaha
United StatesAbgeschlossen» Google-MapsComprehensive Cancer Centers of Nevada
89169 Las Vegas
United StatesAbgeschlossen» Google-MapsRutgers Cancer Institute of New Jersey
08903 New Brunswick
United StatesZurückgezogen» Google-MapsWeill Medical College of Cornell University
10021 New York
United StatesRekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center
10065 New York
United StatesZurückgezogen» Google-MapsLevine Cancer Institute
28204 Charlotte
United StatesAbgeschlossen» Google-MapsHematology Oncology Associates, PC
97504 Medford
United StatesAbgeschlossen» Google-MapsNorthwest Cancer Specialists PC
97062 Tualatin
United StatesAbgeschlossen» Google-MapsPenn State Milton S. Hershey Medical Ctr.
17033 Hershey
United StatesAbgeschlossen» Google-MapsUniversity of Pittsburgh Medical Center (UPMC)
15232 Pittsburgh
United StatesAbgeschlossen» Google-MapsCarolina Urologic Research Center
29572 Myrtle Beach
United StatesAbgeschlossen» Google-MapsSCRI - Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-MapsTexas Oncology-Dallas Presbyterian Hospital
75231 Dallas
United StatesAbgeschlossen» Google-MapsTexas Oncology - Sammons Cancer Center
75246 Dallas
United StatesAbgeschlossen» Google-MapsUT Southwestern Medical Center
75390 Dallas
United StatesZurückgezogen» Google-MapsTexas Oncology-Denton South
76210 Denton
United StatesAbgeschlossen» Google-MapsTexas Oncology-Memorial City
77024 Houston
United StatesAbgeschlossen» Google-MapsUniversity of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-MapsVirginia Oncology Associates
23666 Hampton
United StatesAbgeschlossen» Google-MapsUniversity of Wisconsin School of Medicine and Public Health
53792 Madison
United StatesZurückgezogen» Google-MapsLKH-Univ. Klinikum Graz
A-8036 Graz
AustriaAbgeschlossen» Google-MapsKrankenhaus der Barmherzigen Schwestern Linz
4020 Linz
AustriaAbgeschlossen» Google-MapsMedical University Vienna
A-1090 Vienna
AustriaAbgeschlossen» Google-MapsO.L.V. Ziekenhuis
9300 Aalst
BelgiumAbgeschlossen» Google-MapsCliniques Universitaires Saint Luc
1200 Brussel
BelgiumAbgeschlossen» Google-MapsClinique Notre Dame
6000 Charleroi
BelgiumAbgeschlossen» Google-MapsU.Z. Gent
9000 Gent
BelgiumAbgeschlossen» Google-MapsGZA Ziekenhuizen- Campus St Augustinus
2610 Wilrijk
BelgiumAbgeschlossen» Google-MapsICO, Site Paul Papin
49055 ANGERS Cedex
FranceAbgeschlossen» Google-MapsInstitut Bergonié
Bordeaux
FranceAbgeschlossen» Google-MapsCentre Francois Baclesse
14076 Caen Cédex 05
FranceAbgeschlossen» Google-MapsCentre Georges-François Leclerc
21000 Dijon
FranceAbgeschlossen» Google-MapsCentre Leon Bérard
69008 Lyon
FranceAbgeschlossen» Google-MapsCentre Antoine Lacassagne
06189 Nice Cedex 2
FranceRekrutierend» Google-MapsInstitut de Cancérologie du Gard
30029 Nîmes
FranceRekrutierend» Google-MapsHospital Saint-Louis
75475 Paris Cedex 10
FranceRekrutierend» Google-MapsHopital Europeen Georges-Pompidou
75908 Paris Cedex 15
FranceAbgeschlossen» Google-MapsI.C.O. René Gauducheau
44805 Saint Herblain Cedex
FranceAbgeschlossen» Google-MapsHopital Foch
92150 Suresnes
FranceAbgeschlossen» Google-MapsInstitut Universitaire du Cancer Toulouse - Oncopole
31059 Toulouse cedex 09
FranceZurückgezogen» Google-MapsGustave Roussy
94805 Villejuif Cedex
FranceRekrutierend» Google-MapsSoroka Medical Center
84101 Beer Sheba
IsraelAbgeschlossen» Google-MapsAsaf Harofe Medical Center
60930 Beer Yaakov
IsraelAbgeschlossen» Google-MapsRambam Medical Center
31096 Haifa
IsraelAbgeschlossen» Google-MapsMeir Medical Center
44281 Kfar-Saba
IsraelAbgeschlossen» Google-MapsRabin Medical Center - Bellins
49100 Petah Tikva
IsraelAbgeschlossen» Google-MapsSourasky Medical Center, Tel Aviv Sourasky Med Ctr
64239 Tel-Aviv
IsraelAbgeschlossen» Google-MapsUnità Operativa di Oncologia Medica
52100 Arezzo
ItalyAktiv, nicht rekrutierend» Google-MapsOncologia-IRCCS IRST
47014 Meldola
ItalyAktiv, nicht rekrutierend» Google-MapsFondazione IRCCS Istituto Nazionale dei Tumori
20100 Milano
ItalyAktiv, nicht rekrutierend» Google-MapsOncologia Medica A - Ist Naz Tumori G Pascale
80131 Napoli
ItalyAbgeschlossen» Google-MapsOspedale Maggiore della Carità
28100 Novara
ItalyAbgeschlossen» Google-MapsOncologia Medica Azienda Sanitaria Ospedaliera San Luigi Gonzaga
10043 Orbassano
ItalyAbgeschlossen» Google-MapsIstituto Oncologico Veneto - IRCCS
35128 Padova
ItalyAbgeschlossen» Google-MapsOncologia Medica - Azienda Ospedaliero Universitaria Di Parma
43126 Parma
ItalyAktiv, nicht rekrutierend» Google-MapsAzienda Ospedaliero Universitaria Pisana
56126 Pisa
ItalyAbgeschlossen» Google-MapsAzienda Ospedaliera San Camillo - Roma
00152 Roma
ItalyAbgeschlossen» Google-MapsUOC di Oncologia Medica Università Cattolica del Sacro Cuore Policlinico Universitario A. Gemelli
00168 Roma
ItalyAbgeschlossen» Google-MapsUniversity Hospital Umberto I
00161 Rome
ItalyAbgeschlossen» Google-MapsIstituto Clinico Humanitas UO di Emodinamica e Cradiologia Interventistica
20089 Rozzano
ItalyAbgeschlossen» Google-MapsOncologia Medica-Città Della Salute E Della Scienza Di Torino
10126 Torino
ItalyAbgeschlossen» Google-MapsAzienda Ospedaliero - Universitaria Ospedali Riuniti
60126 Torrette Di Ancona
ItalyAbgeschlossen» Google-MapsChungnam National University Hospital - Dept. of Internal Medicine
301-721 Daejeon
Korea, Republic ofAbgeschlossen» Google-MapsNational Cancer Center
410-769 Goyangsi
Korea, Republic ofAbgeschlossen» Google-MapsGachon University Gil Medical Center
21565 Incheon
Korea, Republic ofAbgeschlossen» Google-MapsSeverance Hospital
03722 Seoul
Korea, Republic ofAbgeschlossen» Google-MapsAsan Medical Center (AMC)
05505 Seoul
Korea, Republic ofAbgeschlossen» Google-MapsSamsung Medical Center
135-710 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-MapsArensia Exploratory Medicine
MD 2025 Chisinau
Moldova, Republic ofAbgeschlossen» Google-MapsSpitalul Clinic de Urologie Prof. Dr. Theodor Burghele
050659 Bucharest
RomaniaAbgeschlossen» Google-MapsSpitalul Clinic Sf. Maria
11172 Bucharest
RomaniaZurückgezogen» Google-MapsInstitutul Clinic Fundeni
022328 Bucuresti
RomaniaZurückgezogen» Google-MapsArensia Exploratory Medicine - Romania
050159 Bucuresti
RomaniaZurückgezogen» Google-MapsInstitutul Oncologic ''Prof Dr. Ion Chiricuta'' Cluj-Napoca
400015 Cluj-Napoca
RomaniaAbgeschlossen» Google-MapsONCOLAB
200385 Craiova
RomaniaAbgeschlossen» Google-MapsInstitutul Regional de Oncologie Iasi
700483 Iasi
RomaniaAbgeschlossen» Google-MapsSpitalul Clinic Municipal De Urgenta Timisoara; Sectia Oncologie
Timisoara
RomaniaZurückgezogen» Google-MapsAltai Regional Oncology Dispensary
656049 Barnaul
Russian FederationAbgeschlossen» Google-MapsCancer Research Center
115478 Moscow N/a
Russian FederationAbgeschlossen» Google-MapsScientific Research Institute of Urology
105425 Moscow
Russian FederationZurückgezogen» Google-MapsHertzen Oncology Research Institute
125284 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-MapsClinical Oncology Dispensary
644013 Omsk
Russian FederationAbgeschlossen» Google-MapsPyatigorsk Regional Oncology Dispensary
357502 Pyatigorsk
Russian FederationAbgeschlossen» Google-MapsLeningradski Regional Oncological Dispensary
191104 Saint-Petersburg
Russian FederationAbgeschlossen» Google-MapsRussian Scientific Center of Radiology and Surgical Technologies
197758 Saint-Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-MapsBashkiria State Medical University
450000 Ufa
Russian FederationAbgeschlossen» Google-MapsHospital Universitari Germans Trias i Pujol
Badalona
SpainAbgeschlossen» Google-MapsHospital Universitario Vall d'Hebron
08035 Barcelona
SpainAbgeschlossen» Google-MapsHospital Clinic de Barcelona
08036 Barcelona
SpainAbgeschlossen» Google-MapsHosp. Univ. de La Princesa
28006 Madrid
SpainNoch nicht rekrutierend» Google-MapsHospital U. Gregorio Marañón
28007 Madrid
SpainAbgeschlossen» Google-MapsFundacion Jimenez Diaz
28020 Madrid
SpainAbgeschlossen» Google-MapsHosp. Univ. Ramon Y Cajal
28034 Madrid
SpainNoch nicht rekrutierend» Google-MapsHosp. Univ. 12 de Octubre
28041 Madrid
SpainNoch nicht rekrutierend» Google-MapsHospital Universitario La Paz
28046 Madrid
SpainAbgeschlossen» Google-MapsCentro Integral Oncológico Clara Campal
28050 Madrid
SpainRekrutierend» Google-MapsHosp. Virgen de La Victoria
29010 Málaga
SpainAbgeschlossen» Google-MapsClinica Universitaria de Navarra
31008 Pamplona
SpainAbgeschlossen» Google-MapsCorporacio Sanitari Parc Tauli
08208 Sabadell
SpainNoch nicht rekrutierend» Google-MapsHosp. Univ. Marques de Valdecilla
39008 Santander
SpainNoch nicht rekrutierend» Google-MapsHospital Virgen del Rocío
41013 Sevilla
SpainAbgeschlossen» Google-MapsHosp. Clinico Univ. de Valencia
46010 Valencia
SpainNoch nicht rekrutierend» Google-MapsTaichung Veterans General Hospital
40705 Taichung
TaiwanAbgeschlossen» Google-MapsNational Cheng Kung University Hospital
70403 Tainan
TaiwanAbgeschlossen» Google-MapsNational Taiwan University Hospital
10002 Taipei
TaiwanAbgeschlossen» Google-MapsChang Gung Memorial Hospital- Linkou
333 Taoyuan
TaiwanAbgeschlossen» Google-MapsRoyal Blackburn Hospital
BB2 3HH Blackburn
United KingdomAbgeschlossen» Google-MapsNinewells Hospital
DD1 9SY Dundee
United KingdomAbgeschlossen» Google-MapsQueens Hospital
RM7 0AG Essex
United KingdomAbgeschlossen» Google-MapsCharing Cross Hospital
W6 8RF London
United KingdomAbgeschlossen» Google-MapsDerriford Hospital
PL6 8DH Plymouth
United KingdomAbgeschlossen» Google-MapsRoyal Marsden Hospital
SM2 5PT Sutton
United KingdomAbgeschlossen» Google-MapsClatterbridge Centre for Oncology
CH63 4JY Wirral
United KingdomAbgeschlossen» Google-Maps
Alle anzeigen 45136 Essen
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-MapsGoethe Universität Frankfurt
60590 Frankfurt
(Hessen)
GermanyZurückgezogen» Google-MapsUniversitatsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-MapsInterdisziplinäres Brustzentrum der Universitätsmedizin Greifswald
Ferdinand-Sauerbruch-Straße
17475 Greifswald Greifswald
(Mecklenburg-Vorpommern)
DeutschlandAbgeschlossen» Google-MapsGeorg-August-Universitaet Goettingen - Innere Medizin - Haematologie, Onkologie
37075 Göttingen
(Niedersachsen)
GermanyAbgeschlossen» Google-MapsAsklepios Klinik Altona
22763 Hamburg
(Hamburg)
GermanyAbgeschlossen» Google-MapsMedizinische Hochschule Hannover;Klinik f. Urologie u. Urologische Onkologie
30625 Hannover
(Niedersachsen)
GermanyAbgeschlossen» Google-MapsUniversity Hospital Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-MapsKlinikum rechts der Isar der TU Muenchen
81675 Muenchen
(Bayern)
GermanyAbgeschlossen» Google-MapsUniversity hospital Muenster, Dpt. of Urology
48129 Muenster
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-MapsCaritas Krankenhaus St. Josef - Innere Medizin II
93053 Regensburg
(Bayern)
GermanyAbgeschlossen» Google-MapsGynäkologisches Krebszentrum am Klinikum St. Elisabeth Straubing
St.-Elisabeth-Straße 23
94315 Straubing
DeutschlandAbgeschlossen» Google-MapsKliniken Nordoberpfalz, Klinik für Urologie
92637 Weiden/Opf
(Bayern)
GermanyAbgeschlossen» Google-MapsMayo Clinic Arizona
85259 Scottsdale
United StatesZurückgezogen» Google-MapsArizona Oncology Associates, PC - NAHOA
86336 Sedona
United StatesAbgeschlossen» Google-MapsUniversity of Arizona Cancer Center
85724 Tucson
United StatesZurückgezogen» Google-MapsMarin Cancer Care Inc.
94904 Greenbrae
United StatesZurückgezogen» Google-MapsCedars Sinai Medical Center - Pediatric Infectious Disease
90048 Los Angeles
United StatesZurückgezogen» Google-MapsRonald Reagan UCLA Medical Center
90095 Los Angeles
United StatesAbgeschlossen» Google-MapsUniversity of California Irvine
92868 Orange
United StatesZurückgezogen» Google-MapsUniversity of California - Davis Medical Center
95817 Sacramento
United StatesAbgeschlossen» Google-MapsStanford University Medical Center
94305 Stanford
United StatesAbgeschlossen» Google-MapsRocky Mountain Cancer Center
80012 Aurora
United StatesAbgeschlossen» Google-MapsGeorgetown Univ. Medical Center - Lombardi Cancer Center
20007 Washington
United StatesAbgeschlossen» Google-MapsNorthwestern University Feinberg School of Medicine
60611 Chicago
United StatesZurückgezogen» Google-MapsUniversity of Chicago
60637 Chicago
United StatesAbgeschlossen» Google-MapsThe University of Iowa - Division of Hematology, Oncology and Blood & Marrow Transplantation
52242 Iowa City
United StatesAbgeschlossen» Google-MapsNorton Cancer Institute
40202 Louisville
United StatesAbgeschlossen» Google-MapsUniv of Michigan Medical Center
48109 Ann Arbor
United StatesZurückgezogen» Google-MapsKarmanos Cancer Institute - Wayne State University
48201 Detroit
United StatesZurückgezogen» Google-MapsMinnesota Oncology
55404 Minneapolis
United StatesAbgeschlossen» Google-MapsNebraska Cancer Specialists
68130 Omaha
United StatesAbgeschlossen» Google-MapsComprehensive Cancer Centers of Nevada
89169 Las Vegas
United StatesAbgeschlossen» Google-MapsRutgers Cancer Institute of New Jersey
08903 New Brunswick
United StatesZurückgezogen» Google-MapsWeill Medical College of Cornell University
10021 New York
United StatesRekrutierend» Google-MapsMemorial Sloan Kettering Cancer Center
10065 New York
United StatesZurückgezogen» Google-MapsLevine Cancer Institute
28204 Charlotte
United StatesAbgeschlossen» Google-MapsHematology Oncology Associates, PC
97504 Medford
United StatesAbgeschlossen» Google-MapsNorthwest Cancer Specialists PC
97062 Tualatin
United StatesAbgeschlossen» Google-MapsPenn State Milton S. Hershey Medical Ctr.
17033 Hershey
United StatesAbgeschlossen» Google-MapsUniversity of Pittsburgh Medical Center (UPMC)
15232 Pittsburgh
United StatesAbgeschlossen» Google-MapsCarolina Urologic Research Center
29572 Myrtle Beach
United StatesAbgeschlossen» Google-MapsSCRI - Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-MapsTexas Oncology-Dallas Presbyterian Hospital
75231 Dallas
United StatesAbgeschlossen» Google-MapsTexas Oncology - Sammons Cancer Center
75246 Dallas
United StatesAbgeschlossen» Google-MapsUT Southwestern Medical Center
75390 Dallas
United StatesZurückgezogen» Google-MapsTexas Oncology-Denton South
76210 Denton
United StatesAbgeschlossen» Google-MapsTexas Oncology-Memorial City
77024 Houston
United StatesAbgeschlossen» Google-MapsUniversity of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-MapsVirginia Oncology Associates
23666 Hampton
United StatesAbgeschlossen» Google-MapsUniversity of Wisconsin School of Medicine and Public Health
53792 Madison
United StatesZurückgezogen» Google-MapsLKH-Univ. Klinikum Graz
A-8036 Graz
AustriaAbgeschlossen» Google-MapsKrankenhaus der Barmherzigen Schwestern Linz
4020 Linz
AustriaAbgeschlossen» Google-MapsMedical University Vienna
A-1090 Vienna
AustriaAbgeschlossen» Google-MapsO.L.V. Ziekenhuis
9300 Aalst
BelgiumAbgeschlossen» Google-MapsCliniques Universitaires Saint Luc
1200 Brussel
BelgiumAbgeschlossen» Google-MapsClinique Notre Dame
6000 Charleroi
BelgiumAbgeschlossen» Google-MapsU.Z. Gent
9000 Gent
BelgiumAbgeschlossen» Google-MapsGZA Ziekenhuizen- Campus St Augustinus
2610 Wilrijk
BelgiumAbgeschlossen» Google-MapsICO, Site Paul Papin
49055 ANGERS Cedex
FranceAbgeschlossen» Google-MapsInstitut Bergonié
Bordeaux
FranceAbgeschlossen» Google-MapsCentre Francois Baclesse
14076 Caen Cédex 05
FranceAbgeschlossen» Google-MapsCentre Georges-François Leclerc
21000 Dijon
FranceAbgeschlossen» Google-MapsCentre Leon Bérard
69008 Lyon
FranceAbgeschlossen» Google-MapsCentre Antoine Lacassagne
06189 Nice Cedex 2
FranceRekrutierend» Google-MapsInstitut de Cancérologie du Gard
30029 Nîmes
FranceRekrutierend» Google-MapsHospital Saint-Louis
75475 Paris Cedex 10
FranceRekrutierend» Google-MapsHopital Europeen Georges-Pompidou
75908 Paris Cedex 15
FranceAbgeschlossen» Google-MapsI.C.O. René Gauducheau
44805 Saint Herblain Cedex
FranceAbgeschlossen» Google-MapsHopital Foch
92150 Suresnes
FranceAbgeschlossen» Google-MapsInstitut Universitaire du Cancer Toulouse - Oncopole
31059 Toulouse cedex 09
FranceZurückgezogen» Google-MapsGustave Roussy
94805 Villejuif Cedex
FranceRekrutierend» Google-MapsSoroka Medical Center
84101 Beer Sheba
IsraelAbgeschlossen» Google-MapsAsaf Harofe Medical Center
60930 Beer Yaakov
IsraelAbgeschlossen» Google-MapsRambam Medical Center
31096 Haifa
IsraelAbgeschlossen» Google-MapsMeir Medical Center
44281 Kfar-Saba
IsraelAbgeschlossen» Google-MapsRabin Medical Center - Bellins
49100 Petah Tikva
IsraelAbgeschlossen» Google-MapsSourasky Medical Center, Tel Aviv Sourasky Med Ctr
64239 Tel-Aviv
IsraelAbgeschlossen» Google-MapsUnità Operativa di Oncologia Medica
52100 Arezzo
ItalyAktiv, nicht rekrutierend» Google-MapsOncologia-IRCCS IRST
47014 Meldola
ItalyAktiv, nicht rekrutierend» Google-MapsFondazione IRCCS Istituto Nazionale dei Tumori
20100 Milano
ItalyAktiv, nicht rekrutierend» Google-MapsOncologia Medica A - Ist Naz Tumori G Pascale
80131 Napoli
ItalyAbgeschlossen» Google-MapsOspedale Maggiore della Carità
28100 Novara
ItalyAbgeschlossen» Google-MapsOncologia Medica Azienda Sanitaria Ospedaliera San Luigi Gonzaga
10043 Orbassano
ItalyAbgeschlossen» Google-MapsIstituto Oncologico Veneto - IRCCS
35128 Padova
ItalyAbgeschlossen» Google-MapsOncologia Medica - Azienda Ospedaliero Universitaria Di Parma
43126 Parma
ItalyAktiv, nicht rekrutierend» Google-MapsAzienda Ospedaliero Universitaria Pisana
56126 Pisa
ItalyAbgeschlossen» Google-MapsAzienda Ospedaliera San Camillo - Roma
00152 Roma
ItalyAbgeschlossen» Google-MapsUOC di Oncologia Medica Università Cattolica del Sacro Cuore Policlinico Universitario A. Gemelli
00168 Roma
ItalyAbgeschlossen» Google-MapsUniversity Hospital Umberto I
00161 Rome
ItalyAbgeschlossen» Google-MapsIstituto Clinico Humanitas UO di Emodinamica e Cradiologia Interventistica
20089 Rozzano
ItalyAbgeschlossen» Google-MapsOncologia Medica-Città Della Salute E Della Scienza Di Torino
10126 Torino
ItalyAbgeschlossen» Google-MapsAzienda Ospedaliero - Universitaria Ospedali Riuniti
60126 Torrette Di Ancona
ItalyAbgeschlossen» Google-MapsChungnam National University Hospital - Dept. of Internal Medicine
301-721 Daejeon
Korea, Republic ofAbgeschlossen» Google-MapsNational Cancer Center
410-769 Goyangsi
Korea, Republic ofAbgeschlossen» Google-MapsGachon University Gil Medical Center
21565 Incheon
Korea, Republic ofAbgeschlossen» Google-MapsSeverance Hospital
03722 Seoul
Korea, Republic ofAbgeschlossen» Google-MapsAsan Medical Center (AMC)
05505 Seoul
Korea, Republic ofAbgeschlossen» Google-MapsSamsung Medical Center
135-710 Seoul
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Studien-Informationen
Detailed Description:This is a multicenter, open-label study (participants will know the identity of study drugs
administered) to evaluate the efficacy and safety of erdafitinib in participants with
urothelial cancer. The study comprises a 30-days Screening Phase, a Treatment Phase comprised
of 28-day treatment cycles that will continue until disease progression or unacceptable
toxicity occurs, and a post-treatment Follow-up Phase that will extend from the
End-of-Treatment Visit until the participant has died, withdraws consent, is lost to
follow-up, or the end of the study, whichever comes first. The end of study is defined as the
date when all participants have completed the study treatment (Regimens 1 to 3) or until the
last participant enrolled under the drug-drug interaction (DDI) substudy completes the end of
treatment visit,(whichever happens last). The purpose of DDI sub-study is to evaluate the
interaction of repeated doses of erdafitinib with a sensitive cytochrome 450 (CYP) 3A
substrate (midazolam) and with an organic cation transporter 2 (OCT2) probe substrate
(metformin). Safety will be monitored throughout the study.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Must have histologic demonstration of metastatic or surgically unresectable urothelial
cancer. Minor components of variant histology such as glandular or squamous
differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or
micropapillary change are acceptable
- Must have measurable disease according to the Response Evaluation Criteria in Solid
Tumors (RECIST, version 1.1) at baseline
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0, 1,
or 2
- Must have adequate bone marrow, liver, and renal function as described in protocol
- Negative pregnancy test (urine or serum beta human chorionic gonadotropin [b-hCG]) at
Screening for women of child bearing potential who are sexually active
- Must have shown disease progression according to RECIST, version 1.1, following prior
chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants
who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or
progression according to RECIST, version 1.1, within 12 months of the last dose are
considered to have received chemotherapy in the metastatic setting. These participants
will be referred to as chemo-refractory participants. (Participants who have shown
disease progression according to RECIST, version 1.1 following prior treatment with
anti-Programmed death-ligand 1 (anti PDL1/PD1) antibodies are also eligible) For DDI
substudy
- Disease progression following prior chemotherapy for metastatic or surgically
unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant
chemotherapy and showed disease recurrence or progression within 12 months of the last
dose are considered to have received chemotherapy in the metastatic setting.
Exclusion Criteria:
- Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with
an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and
mitomycin C, within 6 weeks; in the case of immunotherapy, within 4 weeks) before the
first administration of study drug. Localized palliative radiation therapy (but should
not include radiation to target lesions) and ongoing bisphosphonates and denosumab,
are permitted
- Has persistent phosphate level greater than upper limit of normal (ULN) during
screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical
management
- Has a history of or current uncontrolled cardiovascular disease
- Females who are pregnant, breast-feeding, or planning to become pregnant within 3
months after the last dose of study drug and males who plan to father a child while
enrolled in this study or within 5 months after the last dose of study drug
- Has not recovered from reversible toxicity of prior anticancer therapy (except
toxicities which are not clinically significant such as alopecia, skin discoloration,
or Grade 1 neuropathy)
Studien-Rationale
Primary outcome:1. Percentage of Participants with Best Overall Response (Time Frame - From the start of the study treatment until the end of treatment (1 year)):
The objective response rate is defined as the percentage of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST v1.1) criteria. Per RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to (>=) 30 percent (%) decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary outcome:
1. Progression-free survival (Time Frame - From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (up to 5 years)):
Progression-free survival is defined as the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience a complete response during the study) or death, whichever comes first.
2. Duration of Response (Time Frame - From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (up to 5 years)):
The duration of response (CR or PR) is defined as the earliest date a participant achieved a complete response (CR) or a partial response (PR), calculated from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.
3. Overall survival (Time Frame - From the date of the first dose of study drug until death (up to 5 years)):
Overall survival is defined as the time interval in days between the date of the first dose of study drug and the participant's death from any cause. If the participant is alive or the vital status is unknown, the participant's data will be censored at the date the participant was last known to be alive.
4. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame - Screening up to end of study (up to 5 years)):
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
5. Percentage of Participants With Biomarker Assessment (Time Frame - Baseline up to end of study (up to 5 years)):
Presence of circulating biomarkers (DNA, RNA, or proteins) associated with FGFR aberrations will be observed.
6. Plasma Concentration of Erdafitinib (Time Frame - Baseline up to end of study (up to 5 years))
7. Plasma Clearance of Erdafitinib (Time Frame - Baseline up to end of study (up to 5 years))
8. Volume of Distribution of Erdafitinib (Time Frame - Baseline up to end of study (up to 5 years))
9. Plasma Concentration of Midazolam and its Metabolite (1-OH-midazolam) (Time Frame - Up to 14 days)
10. Plasma Concentration of Metformin (Time Frame - Up to 15 days)
Geprüfte Regime
- Erdafitinib (JNJ-42756493):
8 mg orally once daily for 28 days on a 28 day cycle. - Midazolam:
Participants who enrolled in DDI substudy will receive pretreatment with single dose of midazolam on Day -2 and single dose of midazolam on Day 13. - Metformin:
Participants who enrolled in DDI substudy will receive pretreatment with single dose of metformin on Day -1 and single dose of metformin on Day 14.
Quelle: ClinicalTrials.gov