Clinical trial • Phase III • Oncology

GEMCITABINE HYDROCHLORIDE for High-risk non-muscle-invasive bladder cancer | Bladder cancer

Phase III trial of GEMCITABINE HYDROCHLORIDE for High-risk non-muscle-invasive bladder cancer | Bladder cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
High-risk non-muscle-invasive bladder cancer | Bladder cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-01-2024
First CTIS Authorization Date
13-05-2024

Trial design

Randomised, open-label, investigator's choice of intravesical chemotherapy, including mitomycin (intravesical; product listing shows max total 40 mg) and gemcitabine (intravesical; product listing shows max total 2000 mg).-controlled Phase III trial in Belgium, Romania, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator's choice of intravesical chemotherapy, including Mitomycin (intravesical; product listing shows max total 40 mg) and Gemcitabine (intravesical; product listing shows max total 2000 mg).
Target Sample Size
146

Eligibility

Recruits 146 isVulnerablePopulationSelected = true; subject information sheets and informed consent forms specifically for pregnancy and for pregnant partners are provided (documents titled 'SIS and ICF-Pregnant Partner' and 'SIS and ICF Pregnancy' available in multiple languages). Informed consent is obtained from participants; no procedures for assent of minors are described in the available materials..

Vulnerable Population
isVulnerablePopulationSelected = true; subject information sheets and informed consent forms specifically for pregnancy and for pregnant partners are provided (documents titled 'SIS and ICF-Pregnant Partner' and 'SIS and ICF Pregnancy' available in multiple languages). Informed consent is obtained from participants; no procedures for assent of minors are described in the available materials.

Inclusion criteria

  • {"criterion_text":"-Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only HR-NMIBC (defined as HG Ta or any T1, no CIS)."}
  • {"criterion_text":"-Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded."}
  • {"criterion_text":"-All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for HG UC before randomization. For participants with lamina propria invasion (T1) on the Screening biopsy/TURBT, muscularis propria must be present to rule out MIBC."}
  • {"criterion_text":"-Participants must have received at least 5 of 6 induction doses of BCG (adequate induction) with or without maintenance therapy."}
  • {"criterion_text":"-Diagnosis of recurrent, papillary-only HR-NMIBC (defined as HG Ta or any T1, no CIS) must be within 12 months of the last dose of BCG therapy."}
  • {"criterion_text":"-Participants must be ineligible for or have elected not to undergo RC."}

Exclusion criteria

  • {"criterion_text":"-Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic UC (ie, T2, T3, T4, N+, and/or M+)."}
  • {"criterion_text":"-Must not currently have UC or histological variant at any site outside of the urinary bladder. UC of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization with no evidence of recurrence."}
  • {"criterion_text":"-N+ and/or M+ per BICR of CT/MR Urography."}
  • {"criterion_text":"-Received serial intravesical therapy or systemic therapy from the time of histologic diagnosis of recurrent HR-NMIBC to date of randomization. Immediate post-TURBT single-dose per-operative intravesical chemotherapy is allowed in accordance with institutional guidelines."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-DFS will be measured as the time from randomization to the time of the first recurrence of HR-NMIBC (HG Ta, any T1 or CIS), progression, or death due to any cause, whichever occurs first. Recurrence or progression of DFS events will be determined by central disease assessments of urine cytology, bladder biopsy, or imaging, as applicable.","definition_or_measurement_approach":"Recurrence or progression of DFS events will be determined by central disease assessments of urine cytology, bladder biopsy, or imaging, as applicable."}

Recruitment

Registry Or Advocacy Recruitment
True - Patient Advocacy Groups (PAG) outreach materials are included (no specific external advocacy organisation names provided).
Digital Remote Recruitment
True - recruitment materials include social media posts/ads, video/on-screen text, email templates and digital visual tools across multiple countries.
Planned Sample Size
146
Recruitment Window Months
82
Consent Approach
Informed consent obtained from participants using subject information sheets and ICFs available in multiple languages (documented SIS and ICF materials present for English, French, Dutch, German, Italian, Spanish, Polish, Romanian across country packages). Pregnancy-specific ICFs and partner of pregnant partner ICFs are provided. No assent procedures for minors are described in the available documents.

Methods

  • Country-specific recruitment materials and arrangements (documented Recruitment Arrangements) using flyers, posters, and recruitment leaflets (associated with Belgium, Romania, Italy, France, Germany, Spain, Poland).
  • Digital channels: social media posts and social media adverts (documents titled 'Social Media', 'Social Media Posts', 'Social Media Ad').
  • Email outreach including PAG outreach / PAG Email templates and general recruitment emails.
  • Multimedia: video and on-screen text recruitment materials and a TAR-200 visual tool.
  • Patient advocacy engagement (PAG outreach materials) and outreach to patient groups (country-specific PAG materials referenced).

Geography

Total Number Of Sites
43
Total Number Of Participants
102

Belgium

Earliest CTIS Part Ii Submission Date
16-04-2024
Latest Decision Or Authorization Date
21-05-2024
Processing Time Days
35
Number Of Sites
5
Number Of Participants
10

Sites

Site Name
Ziekenhuis Oost Limburg
Department Name
Urology
Principal Investigator Name
Yannic Raskin
Principal Investigator Email
yannic.raskin@zol.be
Contact Person Name
Yannic Raskin
Contact Person Email
yannic.raskin@zol.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Urology
Principal Investigator Name
Lieven Goeman
Principal Investigator Email
lieven.goeman@azdelta.be
Contact Person Name
Lieven Goeman
Contact Person Email
lieven.goeman@azdelta.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Urology
Principal Investigator Name
Harm Arentsen
Principal Investigator Email
harm.arentsen@azsintjan.be
Contact Person Name
Harm Arentsen
Contact Person Email
harm.arentsen@azsintjan.be
Site Name
Az Maria Middelares Gent
Department Name
Urology
Principal Investigator Name
Karel Decaestecker
Principal Investigator Email
karel.decaestecker@asmmj.be
Contact Person Name
Karel Decaestecker
Contact Person Email
karel.decaestecker@asmmj.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Urology
Principal Investigator Name
Bertrand Tombal
Principal Investigator Email
bertrand.tombal@saintluc.uclouvain.be
Contact Person Name
Bertrand Tombal

Romania

Earliest CTIS Part Ii Submission Date
09-02-2024
Latest Decision Or Authorization Date
06-06-2024
Processing Time Days
118
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Department Name
Urologie
Principal Investigator Name
Razvan Tiberiu Bardan
Principal Investigator Email
razvan.bardan@gmail.com
Contact Person Name
Razvan Tiberiu Bardan
Contact Person Email
razvan.bardan@gmail.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Urologie
Principal Investigator Name
Vlad-Horia Schitcu
Principal Investigator Email
schitcu@yahoo.com
Contact Person Name
Vlad-Horia Schitcu
Contact Person Email
schitcu@yahoo.com
Site Name
Centrul Medical Unirea S.R.L.
Department Name
Urologie
Principal Investigator Name
Marius Neculoiu
Principal Investigator Email
mneculoiu@yahoo.com
Contact Person Name
Marius Neculoiu
Contact Person Email
mneculoiu@yahoo.com
Site Name
Delta Health Care S.R.L.
Department Name
Urologie
Principal Investigator Name
Dragos Georgescu
Principal Investigator Email
dgeorgescu2000@yahoo.com
Contact Person Name
Dragos Georgescu
Contact Person Email
dgeorgescu2000@yahoo.com

Italy

Earliest CTIS Part Ii Submission Date
17-04-2024
Latest Decision Or Authorization Date
20-05-2024
Processing Time Days
33
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Ospedale Generale Provinciale Di Macerata
Department Name
UOC Oncologia
Principal Investigator Name
Nicola Battelli
Principal Investigator Email
nicola.battelli@sanita.marche.it
Contact Person Name
Nicola Battelli
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Urologia U
Principal Investigator Name
Paolo Gontero
Principal Investigator Email
paolo.gontero@unito.it
Contact Person Name
Paolo Gontero
Contact Person Email
paolo.gontero@unito.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Urologia
Principal Investigator Name
Enza Lamanna
Principal Investigator Email
enza.lamanna@auslromagna.it
Contact Person Name
Enza Lamanna
Contact Person Email
enza.lamanna@auslromagna.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Urologia
Principal Investigator Name
Alberto Macchi
Principal Investigator Email
alberto.macchi@istitutotumori.mi.it
Contact Person Name
Alberto Macchi
Site Name
Humanitas Research Hospital
Department Name
Urologia e andrologia
Principal Investigator Name
Massimo Lazzeri
Principal Investigator Email
lazzeri.m@tiscali.it
Contact Person Name
Massimo Lazzeri
Contact Person Email
lazzeri.m@tiscali.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di Oncologia Medica
Principal Investigator Name
Andrea Necchi
Principal Investigator Email
necchi.andrea@hsr.it
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
Fondazione Policlinico Universitario Campus Bio-Medico
Department Name
UOC Oncologia Medica
Principal Investigator Name
Rocco Papalia
Principal Investigator Email
rocco.papalia@unicampus.it
Contact Person Name
Rocco Papalia
Contact Person Email
rocco.papalia@unicampus.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Unità di Urologia
Principal Investigator Name
Giuseppe Simone
Principal Investigator Email
giuseppe.simone@ifo.it
Contact Person Name
Giuseppe Simone
Contact Person Email
giuseppe.simone@ifo.it

France

Earliest CTIS Part Ii Submission Date
03-05-2024
Latest Decision Or Authorization Date
17-05-2024
Processing Time Days
14
Number Of Sites
7
Number Of Participants
14

Sites

Site Name
Hospital Foch
Department Name
Urology
Principal Investigator Name
Yann Neuzillet
Principal Investigator Email
y.neuzillet@hopital-foch.com
Contact Person Name
Yann Neuzillet
Contact Person Email
y.neuzillet@hopital-foch.com
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Urology
Principal Investigator Name
Romain Mathieu
Principal Investigator Email
Romain.MATHIEU@chu-rennes.fr
Contact Person Name
Romain Mathieu
Contact Person Email
Romain.MATHIEU@chu-rennes.fr
Site Name
Capio La Croix Du Sud
Department Name
Urology
Principal Investigator Name
Benjamin Pradere
Principal Investigator Email
benjaminpradere@gmail.com
Contact Person Name
Benjamin Pradere
Contact Person Email
benjaminpradere@gmail.com
Site Name
Polyclinique De Limoges
Department Name
Oncology
Principal Investigator Name
Sabrina Falkowski
Principal Investigator Email
s.falkowski@imro.fr
Contact Person Name
Sabrina Falkowski
Contact Person Email
s.falkowski@imro.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Urology
Principal Investigator Name
Gautier Marcq
Principal Investigator Email
Gautier.MARCQ@chu-lille.fr
Contact Person Name
Gautier Marcq
Contact Person Email
Gautier.MARCQ@chu-lille.fr
Site Name
Institut Paoli-Calmettes
Department Name
Urology
Principal Investigator Name
Géraldine Pignot
Principal Investigator Email
PIGNOTG@ipc.unicancer.fr
Contact Person Name
Géraldine Pignot
Contact Person Email
PIGNOTG@ipc.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Urology
Principal Investigator Name
Evanguelos Xylinas
Principal Investigator Email
evanguelos.xylinas@aphp.fr
Contact Person Name
Evanguelos Xylinas
Contact Person Email
evanguelos.xylinas@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
11-04-2024
Latest Decision Or Authorization Date
16-05-2024
Processing Time Days
35
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Urologie Neandertal - Praxis Mettmann
Principal Investigator Name
Philipp Spiegelhalder
Principal Investigator Email
p_spiegelhalder@web.de
Contact Person Name
Philipp Spiegelhalder
Contact Person Email
p_spiegelhalder@web.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik und Poliklinik fur Urologie
Principal Investigator Name
Axel Merseburger
Principal Investigator Email
axel.merseburger@uksh.de
Contact Person Name
Axel Merseburger
Contact Person Email
axel.merseburger@uksh.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Urologische Klinik und Poliklinik
Principal Investigator Name
Jozefina Casuscelli
Principal Investigator Email
jozefina.casuscelli@med.uni-muenchen.de
Contact Person Name
Jozefina Casuscelli
Site Name
University Hospital Cologne AöR
Department Name
Klinik für Urologie, Uro-Onkologie, spezielle urologische und roboter-assistierte Chirurgie
Principal Investigator Name
Axel Heidenreich
Principal Investigator Email
axel.heidenreich@uk-koeln.de
Contact Person Name
Axel Heidenreich
Contact Person Email
axel.heidenreich@uk-koeln.de
Site Name
Klinikum Leverkusen gGmbH
Principal Investigator Name
Daniel Porres
Principal Investigator Email
daniel.porres@klinikum-lev.de
Contact Person Name
Daniel Porres
Contact Person Email
daniel.porres@klinikum-lev.de
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Universitätsklinik und Poliklinik für Urologie
Principal Investigator Name
Georgios Gakis
Principal Investigator Email
Georgios.Gakis@uk-halle.de
Contact Person Name
Georgios Gakis
Contact Person Email
Georgios.Gakis@uk-halle.de

Spain

Earliest CTIS Part Ii Submission Date
09-02-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
94
Number Of Sites
9
Number Of Participants
18

Sites

Site Name
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Department Name
Urology
Principal Investigator Name
José María Martínez-Jabaloyas
Principal Investigator Email
marjabaloyas@gmail.com
Contact Person Name
José María Martínez-Jabaloyas
Contact Person Email
marjabaloyas@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Urology
Principal Investigator Name
Juan Aragón Chamizo
Principal Investigator Email
jaragonchamizo@gmail.com
Contact Person Name
Juan Aragón Chamizo
Contact Person Email
jaragonchamizo@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Urology
Principal Investigator Name
José Luis Gutiérrez Baños
Principal Investigator Email
joseluis.gutierrez@scsalud.es
Contact Person Name
José Luis Gutiérrez Baños
Contact Person Email
joseluis.gutierrez@scsalud.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Urology
Principal Investigator Name
Félix Guerrero Ramos
Principal Investigator Email
felixguerrero@gmail.com
Contact Person Name
Félix Guerrero Ramos
Contact Person Email
felixguerrero@gmail.com
Site Name
Fundacio Puigvert
Department Name
Urology
Principal Investigator Name
Óscar Rodríguez Faba
Principal Investigator Email
ORODRIGUEZ@fundacio-puigvert.es
Contact Person Name
Óscar Rodríguez Faba
Site Name
Hospital Germans Trias I Pujol
Department Name
Urology
Principal Investigator Name
Pol Vives Servián
Principal Investigator Email
pservian.germanstrias@gencat.cat
Contact Person Name
Pol Vives Servián
Site Name
Parc Tauli Hospital Universitari
Department Name
Urology
Principal Investigator Name
Arturo Domínguez
Principal Investigator Email
adominguez@tauli.cat
Contact Person Name
Arturo Domínguez
Contact Person Email
adominguez@tauli.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Urology
Principal Investigator Name
Antonio Medina
Principal Investigator Email
rantonio.medina.sspa@juntadeandalucia.es
Contact Person Name
Antonio Medina
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Urology
Principal Investigator Name
Bernardo Herrera Imbroda
Principal Investigator Email
ber.urologia@gmail.com
Contact Person Name
Bernardo Herrera Imbroda
Contact Person Email
ber.urologia@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
16-04-2024
Latest Decision Or Authorization Date
20-05-2024
Processing Time Days
34
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
In Vivo Sp. z o.o.
Department Name
not applicable
Principal Investigator Name
Piotr Piasecki
Principal Investigator Email
kontakt@in-vivo.pl
Contact Person Name
Piotr Piasecki
Contact Person Email
kontakt@in-vivo.pl
Site Name
Mazowiecki Szpital Onkologiczny Sp. z o.o.
Department Name
Pododdzial Urologii
Principal Investigator Name
Tomasz Chwalinski
Principal Investigator Email
t.chwalinski@szpitalonkologiczny.pl
Contact Person Name
Tomasz Chwalinski
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
Pododdzial Urologii
Principal Investigator Name
Krzysztof Tupikowski
Principal Investigator Email
krzysztof.tupikowski@dcopih.pl
Contact Person Name
Krzysztof Tupikowski
Contact Person Email
krzysztof.tupikowski@dcopih.pl
Site Name
Szpital Wojewodzki Im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Tarnowie
Department Name
Oddzial Urologii
Principal Investigator Name
Grzegorz Sulimka
Principal Investigator Email
sulimka@lukasz.med.pl
Contact Person Name
Grzegorz Sulimka
Contact Person Email
sulimka@lukasz.med.pl

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
Iqvia Inc.
Responsibilities
code 6
Name
Icon Clinical Research Limited
Responsibilities
PRO
Name
Bioclinica Inc.
Responsibilities
imaging
Name
Almac Clinical Technologies LLC
Responsibilities
code 3
Name
Eresearchtechnology Inc.
Responsibilities
eCOA
Name
Labcorp / Laboratory Corporation Of America Holdings
Responsibilities
central laboratory / laboratory services (code 4)

Third parties

  • {"country":"United States","full_name":"Laboratory Corporation Of America Holdings","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"code 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Omniseq Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Convergent Genomics Inc.","duties_or_roles":"code 4","organisation_type":"Health care"}
  • {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"PRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
JNJ-17000139
Active Substance
GEMCITABINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVESICAL USE
Route
INTRAVESICAL USE
Investigational Product Name
MITOMYCIN
Active Substance
MITOMYCIN
Modality
Small molecule
Routes Of Administration
INTRAVESICAL USE
Route
INTRAVESICAL USE
Maximum Dose
40 mg
Investigational Product Name
GEMCITABINE
Active Substance
GEMCITABINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVESICAL USE
Route
INTRAVESICAL USE
Maximum Dose
2000 mg

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