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New pill could fight bladder cancer when standard therapy fails

NCT ID NCT04172675

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a daily pill called erdafitinib against standard chemotherapy for people with a high-risk bladder cancer that returned after BCG treatment. The study enrolled 107 participants whose tumors have specific FGFR gene changes. The goal was to see if erdafitinib could delay cancer recurrence better than chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Erdafitinib (a targeted cancer pill)
What this could lead to
If it works, this could offer a new oral treatment option for people with a specific type of bladder cancer that has returned after standard therapy.
What could go wrong
This is a phase 2 trial with only 107 participants, so results are preliminary. The drug may not improve recurrence-free survival and can cause side effects like eye or skin problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

107 people

The number who actually took part.

Started

Feb 2020

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed, recurrent, non-muscle-invasive urothelial carcinoma of the bladder. Variant pathology are allowed * Tumor with specified fibroblast growth factor receptor (FGFR) mutations or fusions * Bacillus Calmette- Guerin (BCG)-unresponsive after adequate BCG therapy or BCG experienced participants * Refuses or is not eligible for cystectomy (Cohort 1 and Cohort 2 only) * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-1 * Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * A woman of childbearing potential must have a negative pregnancy test (beta-human chorionic gonadotropin \[beta-hCG\]) (urine or serum) within 7 days before randomization (Cohort 1) or the first dose of study drug (Cohort 2 and Cohort 3) * Adequate bone marrow, liver, and renal function as specified in the protocol Exclusion Criteria: * Histologically confirmed, muscle-invasive (T2 or higher stage) urothelial carcinoma of the bladder * Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure squamous CIS of the bladder * Prior treatment with an FGFR inhibitor * Active malignancies other than the disease being treated under study. The only allowed exceptions are: (a) skin cancer treated within the last 24 months that is considered completely cured (b) adequately treated lobular carcinoma in situ (LCIS) and ductal CIS (c) history of localized breast cancer and receiving antihormonal agents, or history of localized prostate cancer (N0M0) and receiving androgen deprivation therapy * Current central serous retinopathy or retinal pigment epithelial detachment of any grade

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Conditions

The condition(s) this trial relates to.

Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary bladder neoplasms

Contacts and locations

Locations

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • Albany Medical College

    Albany, New York, 12208, United States

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800, Belgium

  • Asahi General Hospital

    Chiba, 289-2511, Japan

  • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

    Goiânia, 74605-070, Brazil

  • Azienda Ospedaliera ''Vito Fazzi''

    Lecce, 73100, Italy

  • Azienda Ospedaliera Sant Andrea

    Roma, 00189, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126, Italy

  • CEMIC Saavedra

    Buenos Aires, C1431FWN, Argentina

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650, Brazil

  • CHP Saint Gregoire

    Saint-Grégoire, 35760, France

  • CHU De Poitiers

    Poitiers, 86021, France

  • CHU Gabriel-Montpied

    Clermont-Ferrand, 63000, France

  • CHU Sart-Tilman

    Liège, 4000, Belgium

  • CIMET s Inamdar Multispeciality Hospital

    Pune, 411040, India

  • CUROS - Uberörtliche urologische Gemeinschaftspraxis

    Wesseling, 50389, Germany

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000, Argentina

  • Centre Hospitalier Universitaire de Nancy - Hôpital Central

    Vandœuvre-lès-Nancy, 54519, France

  • Centro Urologico Profesor Bengio

    Córdoba, X5000KPH, Argentina

  • Chang Gung Memorial Hospital- Linkou

    Taoyuan County, 33305, Taiwan

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35033, France

  • Chungbuk National University Hospital

    Cheongju-si, 361-711, South Korea

  • City Clinic Sp. z o.o.

    Warsaw, 02-473, Poland

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208, Spain

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Ente Ecclesiastico Ospedale Generale Regionale F. Miulli

    Acquaviva delle Fonti, 70021, Italy

  • Fakultni nemocnice u sv. Anny v Brne

    Brno, 656 91, Czechia

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Flinders Medical Centre

    Bedford Park, 5042, Australia

  • Fondazione G Pascale Istituto Nazionale Tumori IRCCS

    Naples, 80138, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fondazione Istituto G. Giglio

    Cefalù, 90015, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Fujita Health University Hospital

    Toyoake, 470-1192, Japan

  • Fund. Puigvert

    Barcelona, 08025, Spain

  • Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000, Brazil

  • Great Lakes Physician PC d/b/a Western New York Urology Associates

    Sanborn, New York, 14132, United States

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris, 75020, France

  • Gunma Prefectural Cancer Center

    Ōta-ku, 373 8550, Japan

  • Gustave Roussy

    Villejuif, 94800, France

  • Hakodate Goryoukaku Hospital

    Hakodate, 040 8611, Japan

  • Health Care Global Enterprises pvt Ltd

    Bangalore, 560027, India

  • Hitachi General Hospital

    Hitachi, 317-0077, Japan

  • Hopital Bichat Claude Bernard

    Paris, 75877, France

  • Hopital Charles Nicolle

    Rouen, 76031, France

  • Hopital Huriez

    Lille, 59037, France

  • Hopital Pellegrin CHU Bordeaux

    Bordeaux, 33076, France

  • Hosp Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital Britanico de Buenos Aires

    Buenos Aires, Argentina

  • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

    Ribeirão Preto, 14048-900, Brazil

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de, C1199ABB, Argentina

  • Hospital Nossa Senhora da Conceicao S A

    Porto Alegre, 91350 200, Brazil

  • Hospital Privado de Cordoba

    Córdoba, XX5016KEH, Argentina

  • Hôpital Edouard Herriot

    Lyon, 69437, France

  • Hôpital Universitaire Pitié-Salpêtrière

    Paris, 75013, France

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31000, France

  • Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

    São Paulo, 04039-004, Brazil

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001, Brazil

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife, 50070-550, Brazil

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170, Brazil

  • JOHAS Osaka Rosai Hospital

    Osaka, 591-8025, Japan

  • Juntendo University Hospital

    Bunkyō City, 113 8431, Japan

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • King Georges Medical University

    Lucknow, 226003, India

  • Klinikum Herne - Urologie

    Herne, 44625, Germany

  • Klinikum rechts der Isar - III. Med. Klinik und Poliklinik

    München, 81675, Germany

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Krajská nemocnice Liberec

    Liberec, 460 63, Czechia

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59075-740, Brazil

  • Liga Paranaense de Combate ao Cancer

    Curitiba, 81520 060, Brazil

  • Lister Hospital

    Stevenage, SG1 4AB, United Kingdom

  • MVZ Urologie 24 gGmbH

    Nuremberg, 90491, Germany

  • Macquarie University

    Macquarie University, 2109, Australia

  • Medical College of Wisconsin Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Medical Concierge Centrum Medyczne

    Warsaw, 02 798, Poland

  • Meenakshi Mission Hospital and Research Center

    Madurai, 625107, India

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Muljibhai Patel Urological Hospital

    Nadiād, 387001, India

  • NYU Langone Health

    New York, New York, 10016, United States

  • Nagoya University Hospital

    Nagoya, 466 8560, Japan

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oncocentro Ceará

    Fortaleza, 60135-237, Brazil

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250 905, Brazil

  • Oregon Health And Science University

    Portland, Oregon, 97239, United States

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki, 569-8686, Japan

  • Ospedale Civile di Guastalla

    Guastalla, 42016, Italy

  • Ospedale Regionale Umberto Parini

    Aosta, 11100, Italy

  • Peter MacCallum Cancer Centre

    Melbourne, 3000, Australia

  • Pratia MCM Krakow

    Krakow, 30-727, Poland

  • Praxisklinik Urologie Rhein/Ruhr - Germany

    Mülheim, 45468, Germany

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Rajiv Gandhi Cancer Institute & Research Centre

    Delhi, 110085, India

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200240, China

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298, Japan

  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

    Szczecin, 70-111, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Simmons Cancer Institute

    Springfield, Illinois, 62702, United States

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    Buenos Aires, C1419AHN, Argentina

  • Sociedade Beneficente de Senhoras Hospital Sirio Libanes

    São Paulo, 01308 901, Brazil

  • St Marianna University Hospital

    Kanagawa, 216 8511, Japan

  • St Vincent s Hospital Sydney

    Darlinghurst, 2010, Australia

  • Studienpraxis Urologie Drs. Feyerabend

    Nürtingen, 72622, Germany

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550, Japan

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • The Ohio State University- James Cancer Hospital

    Columbus, Ohio, 43221, United States

  • The Urology Center of Colorado

    Denver, Colorado, 80211, United States

  • The Urology Group

    Cincinnati, Ohio, 45212, United States

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113 8519, Japan

  • Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030, China

  • Toranomon Hospital

    Tokyo, 105-8470, Japan

  • UOC Oncologia Ospedale Provinciale di Macerata

    Province of Macerata, 62100, Italy

  • USC Institute of Urology

    Los Angeles, California, 90033, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universirty of Sheffield Teaching Hospitals NHS Trust

    Sheffield, S10 2JF, United Kingdom

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitatsklinikum Schleswig Holstein Campus Lubeck

    Lübeck, 23538, Germany

  • University of Kansas

    Westwood, Kansas, 66205, United States

  • University of Pittsburgh Medical Center - Cancer Centers

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Tsukuba Hospital

    Tsukuba, 305 8576, Japan

  • University of Washington

    Seattle, Washington, 98008, United States

  • Uniwersytecki Szpital Kliniczny

    Wroclaw, 50-556, Poland

  • Uniwersytecki Szpital Kliniczny im. Fryderyka Chopina w Rzeszowie

    Rzeszów, 35-055, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214, Poland

  • Urological Associates of Southern Arizona, P.C.

    Tucson, Arizona, 85741, United States

  • Urological Research Network

    Hialeah, Florida, 33016, United States

  • Urologicum Duisburg

    Duisburg, 47169, Germany

  • Urology Associates

    Nashville, Tennessee, 37209, United States

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08, Czechia

  • Yokohama City University Medical Center

    Yokohama, 232 0024, Japan

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