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BRIEF TITLE: Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations


  • Org Study ID: CR105065
  • Secondary ID: 42756493BLC2001,2014-002408-26
  • NCT ID: NCT02365597
  • NCT Alias:
  • Sponsor: Janssen Research & Development, LLC - Industry
  • Source: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

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.

Overal Status Start Date Phase Study Type
Recruiting April 22, 2015 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Percentage of Participants with Best Overall Response

Primary Outcome 1 - Time Frame: From the start of the study treatment until the end of treatment (1 year)

Condition:

  • Urothelial Cancer

Eligibility

Criteria:
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)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

Phone:

Email: JNJ.CT@sylogent.com

Link: To learn how to participate in this trial please click here.

Locations

Facility Status Contact
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United States
Withdrawn
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona 86336
United States
Completed
University of Arizona Cancer Center
Tucson, Arizona 85724
United States
Withdrawn
Marin Cancer Care Inc.
Greenbrae, California 94904
United States
Withdrawn
Cedars Sinai Medical Center - Pediatric Infectious Disease
Los Angeles, California 90048
United States
Withdrawn
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
Completed
University of California Irvine
Orange, California 92868
United States
Not yet recruiting
University of California - Davis Medical Center
Sacramento, California 95817
United States
Completed
Stanford University Medical Center
Stanford, California 94305
United States
Completed
Rocky Mountain Cancer Center
Aurora, Colorado 80012
United States
Completed
Georgetown Univ. Medical Center - Lombardi Cancer Center
Washington, District of Columbia 20007
United States
Completed
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United States
Withdrawn
University of Chicago
Chicago, Illinois 60637
United States
Completed
The University of Iowa - Division of Hematology, Oncology and Blood & Marrow Transplantation
Iowa City, Iowa 52242
United States
Completed
Norton Cancer Institute
Louisville, Kentucky 40202
United States
Completed
Univ of Michigan Medical Center
Ann Arbor, Michigan 48109
United States
Withdrawn
Karmanos Cancer Institute - Wayne State University
Detroit, Michigan 48201
United States
Withdrawn
Minnesota Oncology
Minneapolis, Minnesota 55404
United States
Completed
Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Completed
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Completed
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Withdrawn
Weill Medical College of Cornell University
New York, New York 10021
United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Withdrawn
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Completed
Hematology Oncology Associates, PC
Medford, Oregon 97504
United States
Completed
Northwest Cancer Specialists PC
Tualatin, Oregon 97062
United States
Completed
Penn State Milton S. Hershey Medical Ctr.
Hershey, Pennsylvania 17033
United States
Completed
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania 15232
United States
Completed
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Completed
SCRI - Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas 75231
United States
Completed
Texas Oncology - Sammons Cancer Center
Dallas, Texas 75246
United States
Completed
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Withdrawn
Texas Oncology-Denton South
Denton, Texas 76210
United States
Completed
Texas Oncology-Memorial City
Houston, Texas 77024
United States
Completed
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting
Virginia Oncology Associates
Hampton, Virginia 23666
United States
Completed
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin 53792
United States
Withdrawn
LKH-Univ. Klinikum Graz
Graz, A-8036
Austria
Completed
Krankenhaus der Barmherzigen Schwestern Linz
Linz, 4020
Austria
Completed
Krankenhaus der Barmherzigen Brüder
Vienna, 1020
Austria
Completed
Medical University Vienna
Vienna, A-1090
Austria
Completed
O.L.V. Ziekenhuis
Aalst, 9300
Belgium
Completed
Cliniques Universitaires Saint Luc
Brussel, 1200
Belgium
Completed
Clinique Notre Dame
Charleroi, 6000
Belgium
Completed
U.Z. Gent
Gent, 9000
Belgium
Completed
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk, 2610
Belgium
Completed
ICO, Site Paul Papin
ANGERS Cedex, 49055
France
Completed
Institut Bergonié
Bordeaux,
France
Completed
Centre Francois Baclesse
Caen Cédex 05, 14076
France
Completed
Centre Georges-François Leclerc
Dijon, 21000
France
Completed
Centre Leon Bérard
Lyon, 69008
France
Completed
Centre Antoine Lacassagne
Nice Cedex 2, 06189
France
Recruiting
Institut de Cancérologie du Gard
Nîmes, 30029
France
Recruiting
Hospital Saint-Louis
Paris Cedex 10, 75475
France
Recruiting
Hopital Europeen Georges-Pompidou
Paris Cedex 15, 75908
France
Completed
I.C.O. René Gauducheau
Saint Herblain Cedex, 44805
France
Completed
Hopital Foch
Suresnes, 92150
France
Completed
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse cedex 09, 31059
France
Withdrawn
Gustave Roussy
Villejuif Cedex, 94805
France
Recruiting
Vivantes Klinikum Am Urban, Abt. fur Kardiologie
Berlin, 10967
Germany
Completed
Waldkrankenhaus St. Marien -Urologische Universitätsklinik-
Erlangen, 91054
Germany
Completed
Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
Essen, 45136
Germany
Completed
Goethe Universität Frankfurt
Frankfurt, 60590
Germany
Withdrawn
Universitatsklinikum Freiburg
Freiburg, 79106
Germany
Completed
Universitätsmedizin Greifswald
Greifswald, 17475
Germany
Completed
Georg-August-Universitaet Goettingen - Innere Medizin - Haematologie, Onkologie
Göttingen, 37075
Germany
Completed
Asklepios Klinik Altona
Hamburg, 22763
Germany
Completed
Medizinische Hochschule Hannover;Klinik f. Urologie u. Urologische Onkologie
Hannover, 30625
Germany
Completed
University Hospital Heidelberg
Heidelberg, 69120
Germany
Completed
Klinikum rechts der Isar der TU Muenchen
Muenchen, 81675
Germany
Completed
University hospital Muenster, Dpt. of Urology
Muenster, 48129
Germany
Completed
Caritas Krankenhaus St. Josef - Innere Medizin II
Regensburg, 93053
Germany
Completed
Klinikum St. Elisabeth
Straubing, 94315
Germany
Completed
Kliniken Nordoberpfalz, Klinik für Urologie
Weiden/Opf, 92637
Germany
Completed
Soroka Medical Center
Beer Sheba, 84101
Israel
Completed
Asaf Harofe Medical Center
Beer Yaakov, 60930
Israel
Completed
Rambam Medical Center
Haifa, 31096
Israel
Completed
Meir Medical Center
Kfar-Saba, 44281
Israel
Completed
Rabin Medical Center - Bellins
Petah Tikva, 49100
Israel
Completed
Sourasky Medical Center, Tel Aviv Sourasky Med Ctr
Tel-Aviv, 64239
Israel
Completed
Unità Operativa di Oncologia Medica
Arezzo, 52100
Italy
Active, not recruiting
Oncologia-IRCCS IRST
Meldola, 47014
Italy
Active, not recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, 20100
Italy
Active, not recruiting
Oncologia Medica A - Ist Naz Tumori G Pascale
Napoli, 80131
Italy
Completed
Ospedale Maggiore della Carità
Novara, 28100
Italy
Completed
Oncologia Medica Azienda Sanitaria Ospedaliera San Luigi Gonzaga
Orbassano, 10043
Italy
Completed
Istituto Oncologico Veneto - IRCCS
Padova, 35128
Italy
Completed
Oncologia Medica - Azienda Ospedaliero Universitaria Di Parma
Parma, 43126
Italy
Active, not recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Italy
Completed
Azienda Ospedaliera San Camillo - Roma
Roma, 00152
Italy
Completed
UOC di Oncologia Medica Università Cattolica del Sacro Cuore Policlinico Universitario A. Gemelli
Roma, 00168
Italy
Completed
University Hospital Umberto I
Rome, 00161
Italy
Completed
Istituto Clinico Humanitas UO di Emodinamica e Cradiologia Interventistica
Rozzano, 20089
Italy
Completed
Oncologia Medica-Città Della Salute E Della Scienza Di Torino
Torino, 10126
Italy
Completed
Azienda Ospedaliero - Universitaria Ospedali Riuniti
Torrette Di Ancona, 60126
Italy
Completed
Chungnam National University Hospital - Dept. of Internal Medicine
Daejeon, 301-721
Korea, Republic of
Completed
National Cancer Center
Goyangsi, 410-769
Korea, Republic of
Completed
Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic of
Completed
Severance Hospital
Seoul, 03722
Korea, Republic of
Completed
Asan Medical Center (AMC)
Seoul, 05505
Korea, Republic of
Completed
Samsung Medical Center
Seoul, 135-710
Korea, Republic of
Active, not recruiting
Arensia Exploratory Medicine
Chisinau, MD 2025
Moldova, Republic of
Completed
Spitalul Clinic de Urologie Prof. Dr. Theodor Burghele
Bucharest, 050659
Romania
Completed
Spitalul Clinic Sf. Maria
Bucharest, 11172
Romania
Withdrawn
Institutul Clinic Fundeni
Bucuresti, 022328
Romania
Withdrawn
Arensia Exploratory Medicine - Romania
Bucuresti, 050159
Romania
Withdrawn
Institutul Oncologic ''Prof Dr. Ion Chiricuta'' Cluj-Napoca
Cluj-Napoca, 400015
Romania
Completed
ONCOLAB
Craiova, 200385
Romania
Completed
Institutul Regional de Oncologie Iasi
Iasi, 700483
Romania
Completed
Spitalul Clinic Municipal De Urgenta Timisoara; Sectia Oncologie
Timisoara,
Romania
Withdrawn
Altai Regional Oncology Dispensary
Barnaul, 656049
Russian Federation
Active, not recruiting
Cancer Research Center
Moscow N/a, 115478
Russian Federation
Completed
Scientific Research Institute of Urology
Moscow, 105425
Russian Federation
Withdrawn
Hertzen Oncology Research Institute
Moscow, 125284
Russian Federation
Active, not recruiting
Clinical Oncology Dispensary
Omsk, 644013
Russian Federation
Completed
Pyatigorsk Regional Oncology Dispensary
Pyatigorsk, 357502
Russian Federation
Completed
Leningradski Regional Oncological Dispensary
Saint-Petersburg, 191104
Russian Federation
Completed
Russian Scientific Center of Radiology and Surgical Technologies
Saint-Petersburg, 197758
Russian Federation
Active, not recruiting
Bashkiria State Medical University
Ufa, 450000
Russian Federation
Completed
Hospital Universitari Germans Trias i Pujol
Badalona,
Spain
Completed
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Spain
Completed
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Completed
Hospital U. Gregorio Marañón
Madrid, 28007
Spain
Completed
Fundacion Jimenez Diaz
Madrid, 28020
Spain
Completed
Hospital Universitario La Paz
Madrid, 28046
Spain
Completed
Centro Integral Oncológico Clara Campal
Madrid, 28050
Spain
Recruiting
Hosp. Virgen de La Victoria
Málaga, 29010
Spain
Completed
Clinica Universitaria de Navarra
Pamplona, 31008
Spain
Completed
Hospital Virgen del Rocío
Sevilla, 41013
Spain
Completed
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
Completed
National Cheng Kung University Hospital
Tainan, 70403
Taiwan
Completed
National Taiwan University Hospital
Taipei, 10002
Taiwan
Completed
Chang Gung Memorial Hospital- Linkou
Taoyuan, 333
Taiwan
Completed
Royal Blackburn Hospital
Blackburn, BB2 3HH
United Kingdom
Completed
Ninewells Hospital
Dundee, DD1 9SY
United Kingdom
Completed
Queens Hospital
Essex, RM7 0AG
United Kingdom
Completed
Charing Cross Hospital
London, W6 8RF
United Kingdom
Completed
Derriford Hospital
Plymouth, PL6 8DH
United Kingdom
Completed
Royal Marsden Hospital
Sutton, SM2 5PT
United Kingdom
Completed
Clatterbridge Centre for Oncology
Wirral, CH63 4JY
United Kingdom
Completed