Clinical trial • Phase III • Oncology
MITOMYCIN (MITOMYCIN C) for Non‑muscle‑invasive bladder cancer (high‑risk) with FGFR alterations
Phase III trial of MITOMYCIN (MITOMYCIN C) for Non‑muscle‑invasive bladder cancer (high‑risk) with FGFR alterations.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non‑muscle‑invasive bladder cancer (high‑risk) with FGFR alterations
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 08-07-2025
- First CTIS Authorization Date
- 03-11-2025
Trial design
Randomised, open-label, investigator's choice of intravesical chemotherapy (comparator products include mitomycin and gemcitabine). dose and schedule not specified in the available record.-controlled Phase III trial in Belgium, Greece, Spain and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Investigator's choice of intravesical chemotherapy (comparator products include Mitomycin and Gemcitabine). Dose and schedule not specified in the available record.
- Biomarker Stratified
- True, biomarker: susceptible FGFR mutation or FGFR fusion (by urine or tumor tissue testing)
- Target Sample Size
- 130
Eligibility
Recruits 130 adults.
Inclusion criteria
- {"criterion_text":"- Histologically confirmed diagnosis by local histopathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded."}
- {"criterion_text":"- Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing"}
- {"criterion_text":"- All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade 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 had either: a. Adequate Induction of BCG (5 of 6 doses) and either 2 of 3 doses of maintenance or 2 of 6 doses of second induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had Adequate induction course (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade >= 2 toxicity requiring BCG discontinuation (BCG-intolerant population)"}
- {"criterion_text":"- Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2"}
- {"criterion_text":"- Must be ineligible for or refusing radical cystectomy (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 urothelial carcinoma (that is [i.e.], T2, T3, T4, N+, and/or M+)"}
- {"criterion_text":"- Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or priormalignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and consideredat very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone),non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer([N0, M0] with a Gleason score less than or equal to [<=] 7a, treated locally only [radical prostatectomy/radiation therapy/focal treatment]) and other malignancy that is consideredat minimal risk of recurrence"}
- {"criterion_text":"- Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210"}
- {"criterion_text":"- A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (>) 4,000 milliliters (mL)"}
- {"criterion_text":"- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable"}
Endpoints
Primary endpoints
- {"endpoint_text":"- DFS","definition_or_measurement_approach":"Disease‑free survival (DFS). Main objective states: \"To compare DFS between Group A and Group B\" (no further definition provided in the available metadata)"}
Recruitment
- Digital Remote Recruitment
- True, recruitment materials include video scripts and visual tools (TAR-210 Video Script, TAR-210 Visual Tool, Patient Video Storyboards) indicating use of digital media for outreach
- Planned Sample Size
- 130
- Recruitment Window Months
- 76
- Consent Approach
- Informed consent obtained using country-specific Subject Information Sheets (SIS) and Informed Consent Forms (ICF). Pre-screening and main ICF versions are provided; documents exist in multiple languages (English, French, Dutch, Greek, Spanish, Italian, German). Separate ICFs/appendices are available for withdrawal, pregnancy, pregnant partner and privacy/parents or child-exposed-to-IP issues (country-specific forms referenced).
Methods
- Country-specific recruitment arrangements documents (K1) — English/language-specific versions referenced for Belgium, Greece, Spain, Italy, France, Netherlands, Germany (documents titled e.g. REDACTED_K1_Recruitment arrangements_[COUNTRY]_[LANG])
- Use of FGFR testing flyers (FGFR Testing Flyer) to identify biomarker-positive patients (country-specific K2 recruitment materials listed)
- TAR-210 Visual Tool (graphic materials) used as a recruitment aid (country-specific K2 recruitment material listed)
- Patient Fact Sheets and TAR‑210 Video Script / Patient Video Storyboards to inform potential participants (country-specific K2 materials referenced)
- Local site recruitment via participating hospitals/clinics (Urology departments listed for each country)
Geography
- Total Number Of Sites
- 77
- Total Number Of Participants
- 90
Belgium
- Earliest CTIS Part Ii Submission Date
- 23-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 11
- Number Of Sites
- 7
- 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
- Universitair Ziekenhuis Gent
- Department Name
- Urology
- Principal Investigator Name
- Charles Van Praet
- Principal Investigator Email
- charles.vanpraet@uzgent.be
- Contact Person Name
- Charles Van Praet
- Contact Person Email
- charles.vanpraet@uzgent.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
- UZ Leuven
- Department Name
- Urology
- Principal Investigator Name
- Ben Van Cleynenbreugel
- Principal Investigator Email
- ben.vancleynenbreugel@uzleuven.be
- Contact Person Name
- Ben Van Cleynenbreugel
- Contact Person Email
- ben.vancleynenbreugel@uzleuven.be
- Site Name
- Hopital Erasme
- Department Name
- Urology
- Principal Investigator Name
- Thierry Roumeguere
- Principal Investigator Email
- thierry.roumeguere@hubruxelles.be
- Contact Person Name
- Thierry Roumeguere
- Contact Person Email
- thierry.roumeguere@hubruxelles.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@mijnziekenhuis.be
- Contact Person Name
- Karel Decaestecker
- Contact Person Email
- karel.decaestecker@mijnziekenhuis.be
Greece
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 88
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- General Hospital Of Thessaloniki Papageorgiou
- Department Name
- 2nd Department of Urology of A.U.TH.
- Principal Investigator Name
- Konstantinos Hatzimouratidis
- Principal Investigator Email
- chatzimouratidis@auth.gr
- Contact Person Name
- Konstantinos Hatzimouratidis
- Contact Person Email
- chatzimouratidis@auth.gr
- Site Name
- General Hospital Of Athens G Gennimatas
- Department Name
- Department of Urology
- Principal Investigator Name
- Konstantinos Doumas
- Principal Investigator Email
- ntoumask@yahoo.com
- Contact Person Name
- Konstantinos Doumas
- Contact Person Email
- ntoumask@yahoo.com
- Site Name
- Sismanogleio General Hospital
- Department Name
- 2nd University Urology Clinic
- Principal Investigator Name
- Andreas Skolarikos
- Principal Investigator Email
- andskol@yahoo.com
- Contact Person Name
- Andreas Skolarikos
- Contact Person Email
- andskol@yahoo.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- 1st Department of Urology
- Principal Investigator Name
- Konstantinos Stravodimos
- Principal Investigator Email
- kgstravod@gmail.com
- Contact Person Name
- Konstantinos Stravodimos
- Contact Person Email
- kgstravod@gmail.com
- Site Name
- Athens Medical Center S.A.
- Department Name
- 3rd Oncology Department
- Principal Investigator Name
- Petros Sountoulidis
- Principal Investigator Email
- psountoulidis@auth.gr
- Contact Person Name
- Petros Sountoulidis
- Contact Person Email
- psountoulidis@auth.gr
- Site Name
- General University Hospital Of Patras
- Department Name
- Urology Department
- Principal Investigator Name
- Evangelos Liatsikos
- Principal Investigator Email
- liatsikos@yahoo.com
- Contact Person Name
- Evangelos Liatsikos
- Contact Person Email
- liatsikos@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 05-11-2025
- Processing Time Days
- 33
- Number Of Sites
- 18
- Number Of Participants
- 18
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Urology
- Principal Investigator Name
- Mario Álvarez
- Principal Investigator Email
- malvarezmaestro@hotmail.com
- Contact Person Name
- Mario Álvarez
- Contact Person Email
- malvarezmaestro@hotmail.com
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Urology
- Principal Investigator Name
- Sara Martinez Breijo
- Principal Investigator Email
- smarbre@hotmail.com
- Contact Person Name
- Sara Martinez Breijo
- Contact Person Email
- smarbre@hotmail.com
- Site Name
- Hospital De Jerez De La Frontera
- Department Name
- Urology
- Principal Investigator Name
- Nelson Canales
- Principal Investigator Email
- nelsoncanalescasco@gmail.com
- Contact Person Name
- Nelson Canales
- Contact Person Email
- nelsoncanalescasco@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Urology
- Principal Investigator Name
- Mario Domínguez
- Principal Investigator Email
- mario.dominguez@scsalud.es
- Contact Person Name
- Mario Domínguez
- Contact Person Email
- mario.dominguez@scsalud.es
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- Urology
- Principal Investigator Name
- Jesús Rosety Rodriguez
- Principal Investigator Email
- jesusr81@hotmail.com
- Contact Person Name
- Jesús Rosety Rodriguez
- Contact Person Email
- jesusr81@hotmail.com
- Site Name
- Hospital General Universitario De Castellon
- Department Name
- Urology
- Principal Investigator Name
- Miguel Rodrigo
- Principal Investigator Email
- m-rodrigo@hotmail.com
- Contact Person Name
- Miguel Rodrigo
- Contact Person Email
- m-rodrigo@hotmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Urology
- Principal Investigator Name
- Bernardo Herrera
- Principal Investigator Email
- ber.urologia@gmail.com
- Contact Person Name
- Bernardo Herrera
- Contact Person Email
- ber.urologia@gmail.com
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Urology
- Principal Investigator Name
- Arturo Dominguez Garcia
- Principal Investigator Email
- adominguez@tauli.cat
- Contact Person Name
- Arturo Dominguez Garcia
- Contact Person Email
- adominguez@tauli.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Urology
- Principal Investigator Name
- Felix Guerrero
- Principal Investigator Email
- felixguerrero@gmail.com
- Contact Person Name
- Felix Guerrero
- Contact Person Email
- felixguerrero@gmail.com
- Site Name
- Area Sanitaria De Ferrol
- Department Name
- Urology
- Principal Investigator Name
- Andrés Rodríguez
- Principal Investigator Email
- arodri68@gmail.com
- Contact Person Name
- Andrés Rodríguez
- Contact Person Email
- arodri68@gmail.com
- Site Name
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Department Name
- Urology
- Principal Investigator Name
- Antoni Vilaseca Cabo
- Principal Investigator Email
- AVILASEC@clinic.cat
- Contact Person Name
- Antoni Vilaseca Cabo
- Contact Person Email
- AVILASEC@clinic.cat
- Site Name
- Hospital De Jerez De La Frontera (duplicate entry not expected but included in list)
- Department Name
- Urology
- Principal Investigator Name
- Nelson Canales
- Principal Investigator Email
- nelsoncanalescasco@gmail.com
- Contact Person Name
- Nelson Canales
- Contact Person Email
- nelsoncanalescasco@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla (duplicate pattern)
- Department Name
- Urology
- Principal Investigator Name
- Mario Domínguez
- Principal Investigator Email
- mario.dominguez@scsalud.es
- Contact Person Name
- Mario Domínguez
- Contact Person Email
- mario.dominguez@scsalud.es
- Site Name
- Hospital Universitario Puerta Del Mar (duplicate pattern)
- Department Name
- Urology
- Principal Investigator Name
- Jesús Rosety Rodriguez
- Principal Investigator Email
- jesusr81@hotmail.com
- Contact Person Name
- Jesús Rosety Rodriguez
- Contact Person Email
- jesusr81@hotmail.com
- Site Name
- Hospital General Universitario De Castellon (duplicate pattern)
- Department Name
- Urology
- Principal Investigator Name
- Miguel Rodrigo
- Principal Investigator Email
- m-rodrigo@hotmail.com
- Contact Person Name
- Miguel Rodrigo
- Contact Person Email
- m-rodrigo@hotmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria (duplicate pattern)
- Department Name
- Urology
- Principal Investigator Name
- Bernardo Herrera
- Principal Investigator Email
- ber.urologia@gmail.com
- Contact Person Name
- Bernardo Herrera
- Contact Person Email
- ber.urologia@gmail.com
- Site Name
- Parc Tauli Hospital Universitari (duplicate pattern)
- Department Name
- Urology
- Principal Investigator Name
- Arturo Dominguez Garcia
- Principal Investigator Email
- adominguez@tauli.cat
- Contact Person Name
- Arturo Dominguez Garcia
- Contact Person Email
- adominguez@tauli.cat
Italy
- Earliest CTIS Part Ii Submission Date
- 26-09-2025
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 42
- Number Of Sites
- 16
- Number Of Participants
- 16
Sites
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Urologia
- Principal Investigator Name
- Alessandro Crestani
- Principal Investigator Email
- alessandro.crestani@asufc.sanita.fvg.it
- Contact Person Name
- Alessandro Crestani
- Contact Person Email
- alessandro.crestani@asufc.sanita.fvg.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- S.C. Oncologia Clinica Sperimentale Uro-Ginecologica
- Principal Investigator Name
- Sandro Pignata
- Principal Investigator Email
- s.pignata@istitutotumori.na.it
- Contact Person Name
- Sandro Pignata
- Contact Person Email
- s.pignata@istitutotumori.na.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
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- U.O. Urologia
- Principal Investigator Name
- Nazareno Roberto Suardi
- Principal Investigator Email
- nazareno.suardi@unibs.it
- Contact Person Name
- Nazareno Roberto Suardi
- Contact Person Email
- nazareno.suardi@unibs.it
- Site Name
- Azienda Sociosanitaria 3
- Department Name
- SSD Oncologia PO Villa Scassi
- Principal Investigator Name
- Alessia Cavo
- Principal Investigator Email
- alessia.cavo@asl3.liguria.it
- Contact Person Name
- Alessia Cavo
- Contact Person Email
- alessia.cavo@asl3.liguria.it
- Site Name
- Cliniche Gavazzeni S.p.A.
- Department Name
- Urologia
- Principal Investigator Name
- Angelo Porreca
- Principal Investigator Email
- angelo.porreca@gavazzeni.it
- Contact Person Name
- Angelo Porreca
- Contact Person Email
- angelo.porreca@gavazzeni.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- 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
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Urologia
- Principal Investigator Name
- Cristian Fiori
- Principal Investigator Email
- cristian.fiori@unito.it
- Contact Person Name
- Cristian Fiori
- Contact Person Email
- cristian.fiori@unito.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale (duplicate pattern)
- Department Name
- Urologia
- Principal Investigator Name
- Alessandro Crestani
- Principal Investigator Email
- alessandro.crestani@asufc.sanita.fvg.it
- Contact Person Name
- Alessandro Crestani
- Contact Person Email
- alessandro.crestani@asufc.sanita.fvg.it
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale (duplicate pattern)
- Department Name
- S.C. Oncologia Clinica Sperimentale Uro-Ginecologica
- Principal Investigator Name
- Sandro Pignata
- Principal Investigator Email
- s.pignata@istitutotumori.na.it
- Contact Person Name
- Sandro Pignata
- Contact Person Email
- s.pignata@istitutotumori.na.it
- Site Name
- Ospedale San Raffaele S.r.l. (duplicate pattern)
- 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
- Azienda Sociosanitaria 3 (duplicate pattern)
- Department Name
- SSD Oncologia PO Villa Scassi
- Principal Investigator Name
- Alessia Cavo
- Principal Investigator Email
- alessia.cavo@asl3.liguria.it
- Contact Person Name
- Alessia Cavo
- Contact Person Email
- alessia.cavo@asl3.liguria.it
- Site Name
- Cliniche Gavazzeni S.p.A. (duplicate pattern)
- Department Name
- Urologia
- Principal Investigator Name
- Angelo Porreca
- Principal Investigator Email
- angelo.porreca@gavazzeni.it
- Contact Person Name
- Angelo Porreca
- Contact Person Email
- angelo.porreca@gavazzeni.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri (duplicate pattern)
- Department Name
- 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
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga (duplicate pattern)
- Department Name
- Urologia
- Principal Investigator Name
- Cristian Fiori
- Principal Investigator Email
- cristian.fiori@unito.it
- Contact Person Name
- Cristian Fiori
- Contact Person Email
- cristian.fiori@unito.it
France
- Earliest CTIS Part Ii Submission Date
- 19-09-2025
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 52
- Number Of Sites
- 14
- Number Of Participants
- 14
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Early Drug Development and Genitourinary Oncology Group
- Principal Investigator Name
- Yohann LORIOT
- Principal Investigator Email
- Yohann.LORIOT@gustaveroussy.fr
- Contact Person Name
- Yohann LORIOT
- Contact Person Email
- Yohann.LORIOT@gustaveroussy.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
- Site Name
- Institut Paoli Calmettes
- Department Name
- Surgical Oncology 2
- 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
- Centre Hospitalier Prive Saint-Gregoire
- Department Name
- Nord CHP
- Principal Investigator Name
- Romain HUET
- Principal Investigator Email
- terhuet@vivalto-sante.com
- Contact Person Name
- Romain HUET
- Contact Person Email
- terhuet@vivalto-sante.com
- Site Name
- Hopitaux Universitaires Pitie Salpetriere
- Department Name
- Urology
- Principal Investigator Name
- Morgan ROUPRET
- Principal Investigator Email
- morgan.roupret@aphp.fr
- Contact Person Name
- Morgan ROUPRET
- Contact Person Email
- morgan.roupret@aphp.fr
- Site Name
- Capio La Croix Du Sud
- Department Name
- Urology
- Principal Investigator Name
- Benjamin PRADERE
- Principal Investigator Email
- benjamin.pradere@gmail.com
- Contact Person Name
- Benjamin PRADERE
- Contact Person Email
- benjamin.pradere@gmail.com
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci
- Department Name
- Urology
- Principal Investigator Name
- Constance MICHEL
- Principal Investigator Email
- cmichel@ghpsj.fr
- Contact Person Name
- Constance MICHEL
- Contact Person Email
- cmichel@ghpsj.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Claude Vellefaux)
- Department Name
- Urology
- Principal Investigator Name
- Alexandra MASSON
- Principal Investigator Email
- alexandra.massonlecomte@aphp.fr
- Contact Person Name
- Alexandra MASSON
- Contact Person Email
- alexandra.massonlecomte@aphp.fr
- Site Name
- Institut Paoli Calmettes (duplicate pattern)
- Department Name
- Surgical Oncology 2
- 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
- Centre Hospitalier Prive Saint-Gregoire (duplicate pattern)
- Department Name
- Nord CHP
- Principal Investigator Name
- Romain HUET
- Principal Investigator Email
- terhuet@vivalto-sante.com
- Contact Person Name
- Romain HUET
- Contact Person Email
- terhuet@vivalto-sante.com
- Site Name
- Hopitaux Universitaires Pitie Salpetriere (duplicate pattern)
- Department Name
- Urology
- Principal Investigator Name
- Morgan ROUPRET
- Principal Investigator Email
- morgan.roupret@aphp.fr
- Contact Person Name
- Morgan ROUPRET
- Contact Person Email
- morgan.roupret@aphp.fr
- Site Name
- Capio La Croix Du Sud (duplicate pattern)
- Department Name
- Urology
- Principal Investigator Name
- Benjamin PRADERE
- Principal Investigator Email
- benjamin.pradere@gmail.com
- Contact Person Name
- Benjamin PRADERE
- Contact Person Email
- benjamin.pradere@gmail.com
- Site Name
- GIE Groupe hospitalier Paris Saint-Joseph/Vinci (duplicate pattern)
- Department Name
- Urology
- Principal Investigator Name
- Constance MICHEL
- Principal Investigator Email
- cmichel@ghpsj.fr
- Contact Person Name
- Constance MICHEL
- Contact Person Email
- cmichel@ghpsj.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 04-11-2025
- Processing Time Days
- 32
- Number Of Sites
- 12
- Number Of Participants
- 12
Sites
- Site Name
- Klinikum Leverkusen gGmbH
- Department Name
- Klinik für Urologie
- 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
- Heidelberg University
- Department Name
- Uniklinikum Mannheim Klinik für Urologie
- Principal Investigator Name
- Niklas Westhoff
- Principal Investigator Email
- niklas.westhoff@medma.uni-heidelberg.de
- Contact Person Name
- Niklas Westhoff
- Contact Person Email
- niklas.westhoff@medma.uni-heidelberg.de
- Site Name
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
- Department Name
- Marien Hospital Herne; Universitätsklinikum der Ruhr-Universität Bochum; Klinik für Urologie
- Principal Investigator Name
- Karl Tully
- Principal Investigator Email
- karl.tully@elisabethgruppe.de
- Contact Person Name
- Karl Tully
- Contact Person Email
- karl.tully@elisabethgruppe.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Universitätsklinikum Köln (AöR); Klinik für Urologie, Uro-Onkologie
- 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
- Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
- Department Name
- Studienpraxis Urologie Nürtingen
- Principal Investigator Name
- Tilman Todenhöfer
- Principal Investigator Email
- todenhoefer@studienurologie.de
- Contact Person Name
- Tilman Todenhöfer
- Contact Person Email
- todenhoefer@studienurologie.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Caritas Krankenhaus St. Josef; Klinik für Urologie
- Principal Investigator Name
- Marco Schnabel
- Principal Investigator Email
- mschnabel@csj.de
- Contact Person Name
- Marco Schnabel
- Contact Person Email
- mschnabel@csj.de
- Site Name
- Klinikum Leverkusen gGmbH (duplicate pattern)
- Department Name
- Klinik für Urologie
- 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
- Heidelberg University (duplicate pattern)
- Department Name
- Uniklinikum Mannheim Klinik für Urologie
- Principal Investigator Name
- Niklas Westhoff
- Principal Investigator Email
- niklas.westhoff@medma.uni-heidelberg.de
- Contact Person Name
- Niklas Westhoff
- Contact Person Email
- niklas.westhoff@medma.uni-heidelberg.de
- Site Name
- St. Elisabeth Gruppe GmbH (duplicate pattern)
- Department Name
- Marien Hospital Herne; Universitätsklinikum der Ruhr-Universität Bochum; Klinik für Urologie
- Principal Investigator Name
- Karl Tully
- Principal Investigator Email
- karl.tully@elisabethgruppe.de
- Contact Person Name
- Karl Tully
- Contact Person Email
- karl.tully@elisabethgruppe.de
- Site Name
- University Hospital Cologne AöR (duplicate pattern)
- Department Name
- Universitätsklinikum Köln (AöR); Klinik für Urologie, Uro-Onkologie
- 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
- Studienpraxis Urologie Nürtingen (duplicate pattern)
- Department Name
- Studienpraxis Urologie Nürtingen
- Principal Investigator Name
- Tilman Todenhöfer
- Principal Investigator Email
- todenhoefer@studienurologie.de
- Contact Person Name
- Tilman Todenhöfer
- Contact Person Email
- todenhoefer@studienurologie.de
- Site Name
- Universitaetsklinikum Regensburg AöR (duplicate pattern)
- Department Name
- Caritas Krankenhaus St. Josef; Klinik für Urologie
- Principal Investigator Name
- Marco Schnabel
- Principal Investigator Email
- mschnabel@csj.de
- Contact Person Name
- Marco Schnabel
- Contact Person Email
- mschnabel@csj.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-10-2025
- Latest Decision Or Authorization Date
- 06-11-2025
- Processing Time Days
- 16
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Urology
- Principal Investigator Name
- Joost Boormans
- Principal Investigator Email
- j.boormans@erasmusmc.nl
- Contact Person Name
- Joost Boormans
- Contact Person Email
- j.boormans@erasmusmc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Urology
- Principal Investigator Name
- Richard Meijer
- Principal Investigator Email
- rmeijer6@umcutrecht.nl
- Contact Person Name
- Richard Meijer
- Contact Person Email
- rmeijer6@umcutrecht.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Urology
- Principal Investigator Name
- Antoine van der Heijden
- Principal Investigator Email
- toine.vanderheijden@radboudumc.nl
- Contact Person Name
- Antoine van der Heijden
- Contact Person Email
- toine.vanderheijden@radboudumc.nl
- Site Name
- Canisius Wilhelmina Ziekenhuis
- Department Name
- Urology
- Principal Investigator Name
- Diederik Somford
- Principal Investigator Email
- r.somford@cwz.nl
- Contact Person Name
- Diederik Somford
- Contact Person Email
- r.somford@cwz.nl
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- Central Lab
- Name
- Eresearchtechnology Inc.
- Responsibilities
- eCOA services
- Name
- CellCarta
- Responsibilities
- Tissue FGFR Testing
- Name
- Predicine Inc.
- Responsibilities
- Urine FGFR Testing
- Name
- Perceptive Informatics Inc.
- Responsibilities
- Imaging vendor
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA services","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Tissue FGFR Testing","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"Urine FGFR Testing","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging vendor","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MITOMYCIN
- Active Substance
- MITOMYCIN (MITOMYCIN C)
- Modality
- Small molecule
- Routes Of Administration
- INTRAVESICAL USE
- Route
- Intravesical
- Investigational Product Name
- JNJ-42756493 (TAR-210 - erdafitinib intravesical delivery system)
- Active Substance
- ERDAFITINIB
- Modality
- Small molecule
- Routes Of Administration
- INTRAVESICAL USE (delivered via intravesical delivery system and urinary placement catheter)
- Route
- Intravesical
- Investigational Product Name
- GEMCITABINE
- Active Substance
- GEMCITABINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVESICAL USE
- Route
- Intravesical
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