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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

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Kontakt

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
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-Maps
Vivantes Klinikum Am Urban, Abt. fur Kardiologie
10967 Berlin
(Berlin)
GermanyAbgeschlossen» Google-Maps
Waldkrankenhaus St. Marien -Urologische Universitätsklinik-
91054 Erlangen
(Bayern)
GermanyAbgeschlossen» Google-Maps
Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
45136 Essen
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Goethe Universität Frankfurt
60590 Frankfurt
(Hessen)
GermanyZurückgezogen» Google-Maps
Universitatsklinikum Freiburg
79106 Freiburg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Interdisziplinäres Brustzentrum der Universitätsmedizin Greifswald
Ferdinand-Sauerbruch-Straße
17475 Greifswald Greifswald
(Mecklenburg-Vorpommern)
DeutschlandAbgeschlossen» Google-Maps
Georg-August-Universitaet Goettingen - Innere Medizin - Haematologie, Onkologie
37075 Göttingen
(Niedersachsen)
GermanyAbgeschlossen» Google-Maps
Asklepios Klinik Altona
22763 Hamburg
(Hamburg)
GermanyAbgeschlossen» Google-Maps
Medizinische Hochschule Hannover;Klinik f. Urologie u. Urologische Onkologie
30625 Hannover
(Niedersachsen)
GermanyAbgeschlossen» Google-Maps
University Hospital Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyAbgeschlossen» Google-Maps
Klinikum rechts der Isar der TU Muenchen
81675 Muenchen
(Bayern)
GermanyAbgeschlossen» Google-Maps
University hospital Muenster, Dpt. of Urology
48129 Muenster
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Caritas Krankenhaus St. Josef - Innere Medizin II
93053 Regensburg
(Bayern)
GermanyAbgeschlossen» Google-Maps
Gynäkologisches Krebszentrum am Klinikum St. Elisabeth Straubing
St.-Elisabeth-Straße 23
94315 Straubing
DeutschlandAbgeschlossen» Google-Maps
Kliniken Nordoberpfalz, Klinik für Urologie
92637 Weiden/Opf
(Bayern)
GermanyAbgeschlossen» Google-Maps
Mayo Clinic Arizona
85259 Scottsdale
United StatesZurückgezogen» Google-Maps
Arizona Oncology Associates, PC - NAHOA
86336 Sedona
United StatesAbgeschlossen» Google-Maps
University of Arizona Cancer Center
85724 Tucson
United StatesZurückgezogen» Google-Maps
Marin Cancer Care Inc.
94904 Greenbrae
United StatesZurückgezogen» Google-Maps
Cedars Sinai Medical Center - Pediatric Infectious Disease
90048 Los Angeles
United StatesZurückgezogen» Google-Maps
Ronald Reagan UCLA Medical Center
90095 Los Angeles
United StatesAbgeschlossen» Google-Maps
University of California Irvine
92868 Orange
United StatesZurückgezogen» Google-Maps
University of California - Davis Medical Center
95817 Sacramento
United StatesAbgeschlossen» Google-Maps
Stanford University Medical Center
94305 Stanford
United StatesAbgeschlossen» Google-Maps
Rocky Mountain Cancer Center
80012 Aurora
United StatesAbgeschlossen» Google-Maps
Georgetown Univ. Medical Center - Lombardi Cancer Center
20007 Washington
United StatesAbgeschlossen» Google-Maps
Northwestern University Feinberg School of Medicine
60611 Chicago
United StatesZurückgezogen» Google-Maps
University of Chicago
60637 Chicago
United StatesAbgeschlossen» Google-Maps
The University of Iowa - Division of Hematology, Oncology and Blood & Marrow Transplantation
52242 Iowa City
United StatesAbgeschlossen» Google-Maps
Norton Cancer Institute
40202 Louisville
United StatesAbgeschlossen» Google-Maps
Univ of Michigan Medical Center
48109 Ann Arbor
United StatesZurückgezogen» Google-Maps
Karmanos Cancer Institute - Wayne State University
48201 Detroit
United StatesZurückgezogen» Google-Maps
Minnesota Oncology
55404 Minneapolis
United StatesAbgeschlossen» Google-Maps
Nebraska Cancer Specialists
68130 Omaha
United StatesAbgeschlossen» Google-Maps
Comprehensive Cancer Centers of Nevada
89169 Las Vegas
United StatesAbgeschlossen» Google-Maps
Rutgers Cancer Institute of New Jersey
08903 New Brunswick
United StatesZurückgezogen» Google-Maps
Weill Medical College of Cornell University
10021 New York
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesZurückgezogen» Google-Maps
Levine Cancer Institute
28204 Charlotte
United StatesAbgeschlossen» Google-Maps
Hematology Oncology Associates, PC
97504 Medford
United StatesAbgeschlossen» Google-Maps
Northwest Cancer Specialists PC
97062 Tualatin
United StatesAbgeschlossen» Google-Maps
Penn State Milton S. Hershey Medical Ctr.
17033 Hershey
United StatesAbgeschlossen» Google-Maps
University of Pittsburgh Medical Center (UPMC)
15232 Pittsburgh
United StatesAbgeschlossen» Google-Maps
Carolina Urologic Research Center
29572 Myrtle Beach
United StatesAbgeschlossen» Google-Maps
SCRI - Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
Texas Oncology-Dallas Presbyterian Hospital
75231 Dallas
United StatesAbgeschlossen» Google-Maps
Texas Oncology - Sammons Cancer Center
75246 Dallas
United StatesAbgeschlossen» Google-Maps
UT Southwestern Medical Center
75390 Dallas
United StatesZurückgezogen» Google-Maps
Texas Oncology-Denton South
76210 Denton
United StatesAbgeschlossen» Google-Maps
Texas Oncology-Memorial City
77024 Houston
United StatesAbgeschlossen» Google-Maps
University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
Virginia Oncology Associates
23666 Hampton
United StatesAbgeschlossen» Google-Maps
University of Wisconsin School of Medicine and Public Health
53792 Madison
United StatesZurückgezogen» Google-Maps
Krankenhaus der Barmherzigen Schwestern Linz
4020 Linz
AustriaAbgeschlossen» Google-Maps
Cliniques Universitaires Saint Luc
1200 Brussel
BelgiumAbgeschlossen» Google-Maps
GZA Ziekenhuizen- Campus St Augustinus
2610 Wilrijk
BelgiumAbgeschlossen» Google-Maps
Centre Francois Baclesse
14076 Caen Cédex 05
FranceAbgeschlossen» Google-Maps
Centre Georges-François Leclerc
21000 Dijon
FranceAbgeschlossen» Google-Maps
Centre Antoine Lacassagne
06189 Nice Cedex 2
FranceRekrutierend» Google-Maps
Institut de Cancérologie du Gard
30029 Nîmes
FranceRekrutierend» Google-Maps
Hopital Europeen Georges-Pompidou
75908 Paris Cedex 15
FranceAbgeschlossen» Google-Maps
I.C.O. René Gauducheau
44805 Saint Herblain Cedex
FranceAbgeschlossen» Google-Maps
Institut Universitaire du Cancer Toulouse - Oncopole
31059 Toulouse cedex 09
FranceZurückgezogen» Google-Maps
Asaf Harofe Medical Center
60930 Beer Yaakov
IsraelAbgeschlossen» Google-Maps
Rabin Medical Center - Bellins
49100 Petah Tikva
IsraelAbgeschlossen» Google-Maps
Sourasky Medical Center, Tel Aviv Sourasky Med Ctr
64239 Tel-Aviv
IsraelAbgeschlossen» Google-Maps
Unità Operativa di Oncologia Medica
52100 Arezzo
ItalyAktiv, nicht rekrutierend» Google-Maps
Oncologia-IRCCS IRST
47014 Meldola
ItalyAktiv, nicht rekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20100 Milano
ItalyAktiv, nicht rekrutierend» Google-Maps
Oncologia Medica A - Ist Naz Tumori G Pascale
80131 Napoli
ItalyAbgeschlossen» Google-Maps
Ospedale Maggiore della Carità
28100 Novara
ItalyAbgeschlossen» Google-Maps
Oncologia Medica Azienda Sanitaria Ospedaliera San Luigi Gonzaga
10043 Orbassano
ItalyAbgeschlossen» Google-Maps
Istituto Oncologico Veneto - IRCCS
35128 Padova
ItalyAbgeschlossen» Google-Maps
Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma
43126 Parma
ItalyAktiv, nicht rekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Pisana
56126 Pisa
ItalyAbgeschlossen» Google-Maps
Azienda Ospedaliera San Camillo - Roma
00152 Roma
ItalyAbgeschlossen» Google-Maps
UOC di Oncologia Medica Università Cattolica del Sacro Cuore Policlinico Universitario A. Gemelli
00168 Roma
ItalyAbgeschlossen» Google-Maps
Istituto Clinico Humanitas UO di Emodinamica e Cradiologia Interventistica
20089 Rozzano
ItalyAbgeschlossen» Google-Maps
Oncologia Medica-Città Della Salute E Della Scienza Di Torino
10126 Torino
ItalyAbgeschlossen» Google-Maps
Azienda Ospedaliero - Universitaria Ospedali Riuniti
60126 Torrette Di Ancona
ItalyAbgeschlossen» Google-Maps
Chungnam National University Hospital - Dept. of Internal Medicine
301-721 Daejeon
Korea, Republic ofAbgeschlossen» Google-Maps
National Cancer Center
410-769 Goyangsi
Korea, Republic ofAbgeschlossen» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofAbgeschlossen» Google-Maps
Severance Hospital
03722 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Asan Medical Center (AMC)
05505 Seoul
Korea, Republic ofAbgeschlossen» Google-Maps
Samsung Medical Center
135-710 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Arensia Exploratory Medicine
MD 2025 Chisinau
Moldova, Republic ofAbgeschlossen» Google-Maps
Spitalul Clinic de Urologie Prof. Dr. Theodor Burghele
050659 Bucharest
RomaniaAbgeschlossen» Google-Maps
Spitalul Clinic Sf. Maria
11172 Bucharest
RomaniaZurückgezogen» Google-Maps
Institutul Clinic Fundeni
022328 Bucuresti
RomaniaZurückgezogen» Google-Maps
Arensia Exploratory Medicine - Romania
050159 Bucuresti
RomaniaZurückgezogen» Google-Maps
Institutul Oncologic ''Prof Dr. Ion Chiricuta'' Cluj-Napoca
400015 Cluj-Napoca
RomaniaAbgeschlossen» Google-Maps
Institutul Regional de Oncologie Iasi
700483 Iasi
RomaniaAbgeschlossen» Google-Maps
Spitalul Clinic Municipal De Urgenta Timisoara; Sectia Oncologie
Timisoara
RomaniaZurückgezogen» Google-Maps
Altai Regional Oncology Dispensary
656049 Barnaul
Russian FederationAbgeschlossen» Google-Maps
Cancer Research Center
115478 Moscow N/a
Russian FederationAbgeschlossen» Google-Maps
Scientific Research Institute of Urology
105425 Moscow
Russian FederationZurückgezogen» Google-Maps
Hertzen Oncology Research Institute
125284 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Clinical Oncology Dispensary
644013 Omsk
Russian FederationAbgeschlossen» Google-Maps
Pyatigorsk Regional Oncology Dispensary
357502 Pyatigorsk
Russian FederationAbgeschlossen» Google-Maps
Leningradski Regional Oncological Dispensary
191104 Saint-Petersburg
Russian FederationAbgeschlossen» Google-Maps
Russian Scientific Center of Radiology and Surgical Technologies
197758 Saint-Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Bashkiria State Medical University
450000 Ufa
Russian FederationAbgeschlossen» Google-Maps
Hospital Universitari Germans Trias i Pujol
Badalona
SpainAbgeschlossen» Google-Maps
Hospital Universitario Vall d'Hebron
08035 Barcelona
SpainAbgeschlossen» Google-Maps
Hospital Clinic de Barcelona
08036 Barcelona
SpainAbgeschlossen» Google-Maps
Hosp. Univ. de La Princesa
28006 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital U. Gregorio Marañón
28007 Madrid
SpainAbgeschlossen» Google-Maps
Hosp. Univ. Ramon Y Cajal
28034 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Univ. 12 de Octubre
28041 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Centro Integral Oncológico Clara Campal
28050 Madrid
SpainRekrutierend» Google-Maps
Clinica Universitaria de Navarra
31008 Pamplona
SpainAbgeschlossen» Google-Maps
Corporacio Sanitari Parc Tauli
08208 Sabadell
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Univ. Marques de Valdecilla
39008 Santander
SpainNoch nicht rekrutierend» Google-Maps
Hosp. Clinico Univ. de Valencia
46010 Valencia
SpainNoch nicht rekrutierend» Google-Maps
Taichung Veterans General Hospital
40705 Taichung
TaiwanAbgeschlossen» Google-Maps
National Cheng Kung University Hospital
70403 Tainan
TaiwanAbgeschlossen» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanAbgeschlossen» Google-Maps
Chang Gung Memorial Hospital- Linkou
333 Taoyuan
TaiwanAbgeschlossen» Google-Maps
Royal Blackburn Hospital
BB2 3HH Blackburn
United KingdomAbgeschlossen» Google-Maps
Charing Cross Hospital
W6 8RF London
United KingdomAbgeschlossen» Google-Maps
Derriford Hospital
PL6 8DH Plymouth
United KingdomAbgeschlossen» Google-Maps
Royal Marsden Hospital
SM2 5PT Sutton
United KingdomAbgeschlossen» Google-Maps
Clatterbridge Centre for Oncology
CH63 4JY Wirral
United KingdomAbgeschlossen» Google-Maps
Alle anzeigen

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


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